# Innolitics > Innolitics helps medical-device and pharma teams design, build, and clear AI/ML software with the FDA. This file is an llms.txt index ([llmstxt.org](https://llmstxt.org)) of the site's primary content. The links below point directly to clean Markdown copies of each page; the corresponding HTML version lives at the same URL with `index.md` removed. ## Services - [FDA Additional Information Request Response](https://innolitics.com/services/fda-ai-request-response/index.md): FDA identified major cybersecurity, software, or AI/ML deficiencies that you need help resolving. - [FDA Cybersecurity](https://innolitics.com/services/fda-cybersecurity/index.md): You need help preparing cybersecurity documents for an FDA submission or to respond to a Hold Letter. - [Guaranteed AI/ML SaMD 510(k)](https://innolitics.com/services/ai510ks/index.md): We guarantee AI/ML SaMD FDA submission and clearance in 9 months. - [Guaranteed Breakthrough Device Designation in 2 Weeks](https://innolitics.com/services/guaranteed-bdd/index.md): We guarantee your BDD application in 2 weeks. Unlock funding, accelerate FDA review, and signal market leadership. - [Guided 510(k) Service](https://innolitics.com/services/guided-510k/index.md): You need guidance, training, templates, and document review support for a 510(k) submission. - [Medical Device Software Development](https://innolitics.com/services/end-to-end-samd/index.md): You need a software-development partner for a new or existing medical-device product. - [Medical Imaging AI Development](https://innolitics.com/services/medical-imaging-ai-development/index.md): You need a product-development partner for an AI-enabled imaging application. - [Medtech OS](https://innolitics.com/services/medtech-os/index.md): Notion-powered FDA-submission templates and drafting tool. - [Our Services & Solutions](https://innolitics.com/services/index.md): Innolitics offers end-to-end engineering, regulatory, and management consulting services for AI-enabled medical device software. - [QMS Implementation & Support](https://innolitics.com/services/qms/index.md): You need Quality Management System implementation and/or support. - [Regulatory Strategy and Pre-Sub](https://innolitics.com/services/fast-ai-regulatory-strategy/index.md): We guarantee submitting your presub and BDD in 4 weeks. Need it faster? We can do it in as little as 2 weeks with daily meetings and a rush fee. - [US Regulatory Consulting](https://innolitics.com/services/regulatory/index.md): You need to determine the best path to the US market or have other custom regulatory needs. ## Articles - [A note too far. When a letter to file gets a warning letter instead.](https://innolitics.com/articles/Nihon-Kohden-Digital-Health-warning-letter/index.md): FDA publicly rejected Nihon Kohden's letter-to-file decision, so we pulled every warning letter FDA has published — 5,712 of them, 2015–2026 — classified the... - [CMS Is Reopening the Boundary Between AI Medical-Device Software and Clinical Laboratories](https://innolitics.com/articles/cms-clia-ai-software-laboratory-boundary/index.md): CMS and CDC are asking whether AI-assisted postanalytic interpretation, digital pathology, cloud analytics, and data-only medical-device software facilities ... - [How to Read an FDA Guidance Document](https://innolitics.com/articles/how-to-read-an-fda-guidance-document/index.md): A method for studying FDA guidance documents so you can give actionable, correct, and instant advice on a live call: read completely, calibrate on FDA's exam... - [What Should an FDA AI Model Description Include?](https://innolitics.com/articles/fda-ai-medical-device-model-description/index.md): Learn how to write an FDA-ready AI model description covering inputs, outputs, architecture, training, selection, thresholds, pretrained components, limitati... - [Can AI Replace a Consultant? We Built a 1,200-Question Benchmark to Find Out.](https://innolitics.com/articles/consultant-benchmark/index.md): Can a frontier AI model replace your FDA regulatory consultant? We built a private 1,200-question benchmark, an opinionated distillation of 15 years of consu... - [Q2 2026 AI/ML FDA Clearances and De Novos](https://innolitics.com/articles/q-ai-ml-fda-clearances-and-de-novos/index.md): FDA authorized 86 AI/ML devices in Q2 2026, but the sharper signal came after first clearance: 12 Special 510(k)s, 12 PCCPs, two new De Novo categories, and ... - [MDUFA VI vs. MDUFA V: The Side-by-Side Every Regulatory Lead Should Read](https://innolitics.com/articles/mdufa-vi-vs-mdufa-v-the-side-by-side-every-regulatory-lead-should-read/index.md): FDA's draft MDUFA VI commitment letter (FY2028–2032) restructures how sponsors interact with the agency. Seven changes that will reshape submission planning ... - [First FDA-Cleared AI Agent and LLM Enabled Device Confirmed](https://innolitics.com/articles/updoc-fda-cleared-ai-agent/index.md): UpDoc is now the clearest public example of an FDA-cleared LLM-enabled medical device. Here's what FDA actually cleared, why the clinical decision still sits... - [SaMD Fund-Raising: Best Practices, FAQs, and Examples](https://innolitics.com/articles/samd-fund-raising-best-practices-faqs-and-examples/index.md): Notes on medtech funding, covering accelerators and funding sources. - [How much money should an AI SaMD company raise?](https://innolitics.com/articles/ai-samd-fundraising/index.md): For AI SaMD founders deciding how much to raise and how long the first FDA 510(k) will take. A 37-company benchmark: $16.0M market-comparable median, $11.0M ... - [AI in the Pathology Lab: How FDA is Clearing WSI Algorithms- Four Submissions, One Emerging Playbook](https://innolitics.com/articles/ai-in-the-pathology-lab-how-fda-is-clearing-wsi-algorithms-four-submissions-one-emerging-playbook/index.md): Deep dive into four FDA De Novo and 510(k) submissions for AI-powered whole slide image analysis in pathology: Paige Prostate (DEN200080), ArteraAI Prostate ... - [April 2026: 26 AI FDA 510(k) and One De Novo](https://innolitics.com/articles/april-ai-fda-k-and-one-de-novo/index.md): 27 AI/ML medical devices authorized in April 2026. Radiology's share of clearances dropped from 79% to 56%, QIH remains the regulatory plumbing for image-pro... - [How much will an FDA clearance cost?](https://innolitics.com/articles/fda-submission-market-dynamics/index.md): For founders, CEOs, and CFOs at AI/ML medical device companies trying to decide how much to spend on a 510(k). A meta-analysis of 35 post-IPO AI/ML SaMD clea... - [March 2026: 24 AI/ML SaMD Clearances in 31 Days](https://innolitics.com/articles/march-2026-ai-samd-clearances/index.md): FDA cleared 24 AI/ML SaMD applications in March 2026 — one every 31 hours. A breakdown of the patterns that matter for sponsors: radiology dominance, PCCP un... - [Foundation Models in AI SaMD: A Snapshot](https://innolitics.com/articles/foundation-models-ai-samd-snapshot/index.md): FDA's glossary defines foundation models as AI models trained on large, typically unlabeled datasets that are adaptable across a wide range of contexts via f... - [The First AI Otoscope: What TytoCare's De Novo Means for AI in ENT](https://innolitics.com/articles/the-first-ai-otoscope-what-tytocares-de-novo-means-for-ai-in-ent/index.md): TytoCare's De Novo cracked open ENT, a specialty with just five prior AI/ML clearances, and dropped a 510(k) on-ramp for everyone who follows. Inside the 330... - [AI/ML in Digital Pathology and the Software-as-an-IVD Paradigm: 2026 Snapshot](https://innolitics.com/articles/ai-ml-in-digital-pathology-and-the-software-as-an-ivd-paradigm-snapshot/index.md): Fifty-one FDA-authorized pathology AI devices through April 2026, only seven of which are whole-slide imaging algorithms. This snapshot separates the hematol... - [How to Get Your AI-Generated, Vibe-Coded Medical Device FDA-Cleared](https://innolitics.com/articles/ai-generated-code-fda-clearance/index.md): From solo clinicians prototyping algorithms to enterprise teams shipping production software, tools like Cursor, Claude Code, ChatGPT Codex, GitHub Copilot, ... - [Cardiology AI: Signals Over Pixels](https://innolitics.com/articles/cardiology-ai-signals-over-pixels/index.md): A deep dive into the 97 cleared cardiovascular AI/ML SaMD devices, the four archetypes that organize them, and what they reveal about the future of FDA-clear... - [Why We Revisit Our Mission and Values Every Year](https://innolitics.com/articles/why-we-revisit-our-mission-and-values/index.md): A reflection on how Innolitics revisits its mission and values at the annual retreat—and why that exercise sharpens judgment, strengthens alignment, and deep... - [Does FDA Require Software Escrow?](https://innolitics.com/articles/does-fda-require-software-escrow/index.md): Does FDA require software escrow for SaMD? Not necessarily. Learn when escrow helps manage closed-source vendor risk, plus what to include and verify in depo... - [US Senate Mandates New Tailwinds for AI/ML Enabled Medical Devices](https://innolitics.com/articles/us-senate-mandates-new-tailwinds-for-ai-ml-enabled-medical-devices/index.md): The U.S. Senate HELP Committee confirmed what we've been publishing for three years. An analysis of the regulatory signal, what it means for AI device compan... - [What FDA Reviewers Will Ask About Your Bland-Altman Sample Size](https://innolitics.com/articles/bland-altman-sample-size-guide/index.md): A step-by-step guide to using Monte Carlo simulation for estimating the sample size needed to pass Bland-Altman Limits of Agreement acceptance criteria with ... - [How to Get Your Gen AI Device to Market Without Burning Your Runway. Lessons from Kintsugi, Pear, Woebot, and Akili.](https://innolitics.com/articles/gen-ai-device-to-market-without-burning-runway/index.md): Why digital health companies keep dying before and after FDA authorization, the evidence-reimbursement trap strangling the sector, and a post-market-first fr... - [2026 FDA Guidance - Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions](https://innolitics.com/articles/2026-cybersecurity-guidance/index.md): The 2026 FDA guidance on medical device cybersecurity, updated to align cybersecurity expectations with the Quality Management System Regulation (QMSR) and I... - [2026 FDA Guidance - Clinical Decision Support Software](https://innolitics.com/articles/fda-guidance-clinical-decision-support-software-2026/index.md): This FDA guidance clarifies which clinical decision support (CDS) software functions are excluded from the definition of a medical device. - [Analysis of Cuffless Non-invasive Blood Pressure Measuring Devices Guidance – Clinical Performance Testing and Evaluation ](https://innolitics.com/articles/fda-cuffless-bp-guidance-analysis/index.md): Yujans commentary on the new Non-invasive blood pressure measuring device FDA guidance document in response to WHOOP and others. - [Frustrated with Slow AI Adoption? Here’s why. ](https://innolitics.com/articles/ai-native-engineering-transformation/index.md): AI-assisted medical device development is FDA-compliant when done right. The obstacle isn’t regulation. It’s the messy codebase you’ve been ignoring. - [2025 Year in Review: Cardiology AI/ML SaMD 510(k) Clearances](https://innolitics.com/articles/year-in-review-cardiology-ai-ml-samd-k-clearances/index.md): Comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights. - [2026 Clinical Decision Support and General Wellness Guidance Updates](https://innolitics.com/articles/clinical-decision-support-and-general-wellness-guidance-updates/index.md): Side by side differences and executive takeaways from the January 2026 updates to the FDA CDS and General Wellness updates - [Analysis of 510(k) Summary: K232613 CT Cardiomegaly](https://innolitics.com/articles/analysis-of-k232613-ct-cardiomegaly/index.md): A deep dive into K232613 (CT Cardiomegaly) - [AI/ML Medical Device FDA Clearances Week 52 2025](https://innolitics.com/articles/ai-ml-medical-device-fda-clearances-week/index.md): 6 FDA clearances in 10 days. The AI pace is accelerating. Coverage includes neuro, dental, diabetes, and ADHD. Key wins: Nobel Biocare’s implant SDK and Lumo... - [The Dental AI Revolution: A Comprehensive Analysis of 510(k) Clearances (2021-2025)](https://innolitics.com/articles/dental-ai-510k-clearances-2025/index.md): 44 clearances. 18 in 2025 alone. The dental AI market has reached its tipping point. This report dissects the Pearl/Overjet duopoly controlling 34% of the ma... - [Diabeloop’s FDA Clearance: The SiMD to SaMD Transformation Case Study](https://innolitics.com/articles/2025-12-22-Diabeloop-SiMD-to-SaMD-Transformation/index.md): Diabeloop’s DBLG2 clearance proves high-risk SaMD viability, demonstrating how decoupling software from hardware minimizes regulatory burden. - [ How to Build a Medical-Device Timeline You Can Actually Trust](https://innolitics.com/articles/medical-device-project-management/index.md): Are your medical device timelines slipping despite a smart team and lots of effort? This article explains Innolitics’ practical, Gantt-chart-driven approach ... - [2025 Year in Review: AI/ML Medical Device 510(k) Clearances](https://innolitics.com/articles/year-in-review-ai-ml-medical-device-k-clearances/index.md): A data-driven look at 2025’s AI/ML 510(k) clearances: volume, review times, SaMD share, leading specialties, top manufacturers, and early PCCP adoption. - [Weekly AI/ML 510(k)s, De Novos, and BDDs for December 14 to 20](https://innolitics.com/articles/weekly-ai-ml-k-s-de-novos-and-bdds-for-december-to/index.md): Fifteen AI/ML software 510(k) clearances landed in nine days in mid-December 2025. Here’s what got cleared, where it fits clinically, and what it signals for... - [Analysis of 510(k) Summary: K252086 - DTX Studio Assist](https://innolitics.com/articles/analysis-of-k-summary-k-dtx-studio-assist/index.md): Analysis of K252086 (DTX Studio Assist), a strategic 510(k) clearance for a 'headless' SDK. This submission minimizes regulatory burden by offloading UI requ... - [2025 FDA Guidance - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices](https://innolitics.com/articles/fda-guidance-real-world-evidence-medical-devices/index.md): Learn FDA’s updated expectations for using real‑world data to generate real‑world evidence in medical-device submissions—including what makes a data source r... - [Analysis of K252366 a2z-Unified-Triage](https://innolitics.com/articles/K252366/index.md): Deep dive into FDA 510(k) K252366, a2z‑Unified‑Triage, a radiology triage and notification device. Explains why the triage indication is likely the best way ... - [Stop Doing the “Consultant Thing” and Stop Saying “Ideally” ](https://innolitics.com/articles/stop-doing-the-consultant-thing/index.md): A client called out the “consultant thing”: hiding behind “ideally” instead of recommending a real plan. This piece explains why ideal talk wastes time, how ... - [Why you need a Breakthrough Device Designation](https://innolitics.com/articles/why-you-need-a-breakthrough-device-designation/index.md): Breakthrough Device Designation (BDD) is a free, fast FDA program that signals serious unmet need and potential meaningful improvement. For AI/ML SaMD teams,... - [Bland Altman Analysis: Best Practices, FAQs, and Examples](https://innolitics.com/articles/bland-altman-analysis-best-practices-faqs-and-examples/index.md): This article explains Bland–Altman analysis for evaluating agreement between two continuous measurement methods, especially in FDA-facing validation. It show... - [System Items vs. Code Implementation: What FDA Actually Expects](https://innolitics.com/articles/system-item-vs-implementation-fda-expectations/index.md): Practical tips on how to structure your SaMD architecture for FDA review without mirroring your codebase. Explains what the FDA means by “system/software ite... - [Reference Guide for Testing Expectations for AI/ML-Enabled SaMD](https://innolitics.com/articles/ai-ml-samd-testing-expectations-guide/index.md): A “quick” reference guide grouping the example 510(k) clearances by their product code/regulation, summarizing required testing and the rationale behind it. - [FDA Pre-Subs: Best Practices, FAQs, and Examples](https://innolitics.com/articles/fda-pre-subs/index.md): A Pre-Sub is a mechanism for requesting formal written feedback from the FDA, and (optionally) a one-hour meeting. Pre-subs are a useful means to mitigate re... - [What Your First 510(k) Actually Costs You](https://innolitics.com/articles/anatomy-of-510k-with-examples/index.md): Most first-time teams burn over a year overbuilding documentation FDA never asks for. Here is a section-by-section breakdown of a cleared AI/ML SaMD 510(k) (... - [Additional Conditions for Non-Prescription Use: FAQs and Examples](https://innolitics.com/articles/acnu-faq/index.md): An FAQ regarding the FDA’s new ACNU Rule. - [Definitive Guide to AI/ML SaMD Acceptance Criteria](https://innolitics.com/articles/ai-samd-acceptance-criteria/index.md): Setting acceptance criteria incorrectly (too high or too low) can delay your FDA submission by weeks or trigger rejection. This guide analyzed 784 AI/ML medi... - [How to Plan MRMC and Standalone Studies for a 3-Month 510(k)](https://innolitics.com/articles/mrmc-standalone-analysis/index.md): This article shows how to achieve an AI/ML SaMD 510(k) submission in ~3 months by running a compact, well-powered MRMC study while continuously accruing stan... - [Unresolved Anomalies: Best Practices, FAQs, and Examples](https://innolitics.com/articles/unresolved-anomalies/index.md): The “Unresolved Anomalies” document is required for the FDA’s pre-market submissions. This article includes best practices, FAQs, and examples for writing th... - [Definitive Guide to AI/ML SaMD Ground Truthing](https://innolitics.com/articles/adjudication-strategies/index.md): Here we analyze over 200 FDA 510(k) and De Novo summaries to tease out best practices for AI/ML study designs and adjudication strategies specifically. - [Medical Imaging AI/ML Engineering Guide: Best Practices and Examples](https://innolitics.com/articles/medical-imaging-best-practices/index.md): A practical guide for engineers new to medical imaging AI, highlighting common pitfalls—like coordinate-system errors and orientation mix-ups—and providing s... - [Design Inputs: Best Practices, FAQs, and Examples](https://innolitics.com/articles/2022-04-27-design-inputs/index.md): The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article ... - [De Novo Requests for Diagnostic Devices: FAQs and Examples](https://innolitics.com/articles/de-novo-requests-for-diagnostic-devices-faqs-and-examples/index.md): A concise guide to the FDA’s De Novo pathway for novel, moderate-risk medical devices that lack a suitable predicate. It includes real-world examples and off... - [FDA’s Breakthrough Device and STeP Programs: FAQs](https://innolitics.com/articles/fdas-breakthrough-device-and-step-programs-faqs/index.md): Wondering whether FDA’s Breakthrough Device Designation or STeP program is worth the effort? This pocket guide unpacks the program in plain English—what it i... - [Command Line as a Medical Device (CLaMD)](https://innolitics.com/articles/command-line-as-a-medical-device-clamd/index.md): Command Line as a Medical Device (CLaMD) represents a streamlined approach to FDA clearance for medical software. By utilizing command-line interfaces instea... - [Medical Device Cybersecurity: Best Practices, FAQs, and Examples](https://innolitics.com/articles/medical-device-cybersecurity-best-practices-faqs-and-examples/index.md): This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. It also includes examples and ... - [Quality Work Doesn’t Mean Quality Service](https://innolitics.com/articles/quality-work-doesnt-mean-quality-service/index.md): To provide quality service to our clients, we need to do more than produce quality work. - [On Sharing SBOMs](https://innolitics.com/articles/on-sharing-sboms/index.md): In this article, we share a nuanced approach to avoiding sharing sensitive information in an SBOM. - [2025 FDA Guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies](https://innolitics.com/articles/fda-guidance-sex-specific-data-devices-2025/index.md): This guidance applies to sponsors designing or submitting clinical studies for medical devices. It highlights the importance of including and analyzing sex-s... - [10x Coffee Talk: Review of FDA's Latest Draft AI Guidance](https://innolitics.com/articles/x-coffee-talk-review-of-fdas-latest-draft-ai-guidance/index.md): The discussion in the transcript revolves around the FDA’s Draft Guidance on AI in Medical Devices, focusing on regulatory considerations, cybersecurity thre... - [10x Coffee Talk: Image Processing Toolbelt](https://innolitics.com/articles/x-coffee-talk-image-processing-toolbelt/index.md): Kris Huang led a discussion on key image processing techniques in medical imaging, focusing on CT and MRI scans. Topics included histogram equalization, morp... - [Medical Device SBOMs: Best Practices, FAQs, and Examples](https://innolitics.com/articles/sbom-best-practices-faqs-examples/index.md): Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerabilities. - [2025 FDA Guidance - Premarket Approval Application Modular Review](https://innolitics.com/articles/premarket-approval-application-modular-review/index.md): Applicable to sponsors submitting PMAs for medical devices and offers a flexible, staged approach to review. By allowing earlier feedback on individual modul... - [2025 Draft FDA Guidance - Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations](https://innolitics.com/articles/draft-fda-ai-device-software-guidance/index.md): Applies to manufacturers of AI-enabled medical devices and outlines expectations for managing changes to AI software across its lifecycle. It provides recomm... - [10x Coffee Talk: Strategies for PCCP Implementation](https://innolitics.com/articles/x-coffee-talk-strategies-for-pccp-implementation/index.md): A panel discussion about the FDA's Predetermined Change Control Plan (PCCP) guidance, particularly its application to AI-enabled medical devices. The convers... - [Clinical Performance Assessments - Presentation by Ethan Ulrich](https://innolitics.com/articles/clinical-performance-assessments-presentation-by-ethan-ulrich/index.md): The document details the process and significance of Clinical Performance Assessments (CPAs) for medical devices, focusing on their role in regulatory approv... - [How to get AI/ML SaMD FDA cleared - Presentation by: Yujan Shrestha](https://innolitics.com/articles/how-to-get-ai-ml-samd-fda-cleared-presentation-by-yujan-shrestha/index.md): Discussion covered key takeaways from the RSNA conference, balancing safety with speed, and setting risk thresholds. Topics included statistical power, U.S. ... - [Medical Device Recalls - Software Related](https://innolitics.com/articles/medical-device-recalls-software-related/index.md): The discussion outlines the evolution of FDA regulations, common violations, and the enforcement structure. It emphasizes the importance of compliance in med... - [Yujan’s RSNA Talk on AI/ML SaMD](https://innolitics.com/articles/yujan-rsna-talk/index.md): This is a recording of the talk Yujan gave at the RSNA AI Theater - [Webinar - Empowering Regulatory Affairs with AI: Challenges, Insights, and Future Vision](https://innolitics.com/articles/webinar-empowering-regulatory-affairs-with-ai-challenges-insights-and-future-vision/index.md): The growing role of AI in regulatory affairs, emphasizing its potential to enhance efficiency while requiring careful oversight. Challenges like resistance t... - [Yujan's Comments at FDA Digital Health Advisory Committee on GenAI Enabled Medical Devices](https://innolitics.com/articles/yujan-fda-gen-ai-ac-meeting/index.md): Yujan discusses pragmatic postmarket surveillance to FDA advisory committee on GenAI - [10x Coffee Talk: Generative AI and FDA Guidelines](https://innolitics.com/articles/x-coffee-talk-generative-ai-and-fda-guidelines/index.md): The discussion explores generative AI (GenAI) in medical devices, focusing on FDA's considerations for regulation, risks, and the lifecycle management of suc... - [10x Coffee Talk: Threat Modeling and Cybersecurity Risk Management](https://innolitics.com/articles/x-coffee-talk-threat-modeling-and-cybersecurity-risk-management/index.md): The conversation between Yujan Shrestha and J. David Giese focuses on making threat modeling more approachable and less intimidating. They share personal ane... - [FDA Grand Rounds on Synthetic Data](https://innolitics.com/articles/fda-grand-rounds-on-synthetic-data/index.md): Dr. Elena Sizikova's presentation highlights the role of synthetic data in addressing data scarcity and privacy challenges in medical imaging AI. Synthetic d... - [Coffee Time: Medical Device Cybersecurity Threats](https://innolitics.com/articles/coffee-time-medical-device-cybersecurity-threats/index.md): We discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufacturer needs. They highlight risk... - [Coffee Time: Is FDA Doing a Good Job with AI?](https://innolitics.com/articles/coffee-time-is-fda-doing-a-good-job-with-ai/index.md): Yujan and David discussed the topic of FDA's performance in regulating AI medical devices, focusing on the ideal regulatory situation, the impact of AI on ri... - [AI Virtual Scribes: Premarket Performance Evaluation, Risk Management, and Postmarket Performance Monitoring](https://innolitics.com/articles/ai-virtual-scribes-risk-premarket-postmarket/index.md): Explores premarket evaluation, risk management, and postmarket monitoring of AI virtual scribes in healthcare, addressing new challenges in transcription acc... - [FDA Strategy for Foundation Models, Gen AI, LLMs, AI Scribes, and Beyond](https://innolitics.com/articles/gen-ai-foundation-model-fda-strategy-and-presub/index.md): Ideas on how to get foundation models and generative AI FDA cleared. - [10x Talk: Intro to Prompt Engineering](https://innolitics.com/articles/x-talk-intro-to-prompt-engineering/index.md): A 10x talk exploring the basics of prompt engineering, followed by an open-ended discussion. - [Open Source Radiology Foundation Models: A Comprehensive Exploration](https://innolitics.com/articles/open-source-radiology-foundation-models/index.md): Recent advancements in radiology have led to the development of foundation models integrating vision and language capabilities, transforming medical imaging ... - [10x Talk: Guidance on Device Changes: When to Submit a 510(k)](https://innolitics.com/articles/x-talk-guidance-on-device-changes-when-to-submit-a-k/index.md): The talk covers device changes and their regulatory implications using FDA guidance. It focuses on two key documents for deciding when a 510(k) submission is... - [How To Integrate With the VA VistA PACS](https://innolitics.com/articles/vista-software-validation-process/index.md): A practical guide for integrating software with VistA, the VA’s PACS. This guide is based on our experience working through the process with our client. - [The Ultimate 510(k) Checklist](https://innolitics.com/articles/the-ultimate-510k-checklist/index.md): This checklist is meant to assist in the review of a 510(k) submission. It is a version of the checklist we use internally at Innolitics when we’re reviewing... - [How to Document AI/ML Algorithms in FDA Presubmissions (Q-Sub)](https://innolitics.com/articles/how-to-document-ai-ml-algorithms-in-fda-presubmissions-q-sub/index.md): The article outlines a method for documenting AI/ML algorithms for FDA pre-submissions. It emphasizes clear algorithm descriptions to avoid delays. Key steps... - [FDA Cybersecurity Readiness Survey](https://innolitics.com/articles/fda-cybersecurity-readiness-survey/index.md): A survey that should give you a feeling as to whether you’re cybersecurity documentation is ready for an FDA marketing submission. - [2024 Draft FDA Guidance - Predetermined Change Control Plans for Medical Devices](https://innolitics.com/articles/draft-fda-guidance-predetermined-change-control-plans-for-medical-devices/index.md): Provides detailed recommendations on implementing Predetermined Change Control Plans (PCCPs), which allow manufacturers to make some pre-defined changes with... - [PCCPs: Best Practices, FAQs, and Examples](https://innolitics.com/articles/pccps-best-practices-faqs-and-examples/index.md): With predetermined change control plans (PCCPs), FDA has given manufacturers a great new regulatory tool. In this article, we discuss PCCP best practices and... - [How to Avoid 14 Common FDA Cybersecurity Deficiencies](https://innolitics.com/articles/common-cybersecurity-fda-ainn-letter-objections/index.md): How do you avoid slowing down your FDA marketing submission (510(k), De Novo, or PMA) with cybersecurity problems? This article reviews 14 common FDA cyberse... - [SMART on FHIR: Is it a Good Fit for your Medical Device Software?](https://innolitics.com/articles/smart-on-fhir-overview/index.md): Overview of SMART on FHIR and when it’s a good approach to integrating your software into the clinical workflow. It includes a few sequence diagrams and disc... - [Foundation Models (LLM, LAM, LVM, LxM) and FDA Clearance: Best Practices, FAQs, and Presubmission Example](https://innolitics.com/articles/foundation-models-fda-presub-and-faqs/index.md): Tips and FAQs on how to get a foundation model FDA 510(k) or De Novo cleared. - [DICOM Part 15 Security and Medical Device Software](https://innolitics.com/articles/dicom-part-security-and-medical-device-software/index.md): A technical exploration and discussion of DICOM Part 15 Security - [Do You Need DICOM TLS?](https://innolitics.com/articles/do-you-need-dicom-tls/index.md): How safe is DICOM in the wild? As you develop your medical imaging device or service, prepare for the standards and regulations protecting hospital networks ... - [How to Write a Device Description for a 510(k)](https://innolitics.com/articles/how-to-write-a-device-description-for-a-k/index.md): How to Write a Device Description for a 510(k) - [510(k) Preparation Pitfalls: Best Practices, FAQs, and Examples](https://innolitics.com/articles/k-preparation-pitfalls-best-practices-faqs-and-examples/index.md): A comprehensive guide to SaMD 510(k) submissions, featuring an unredacted 510(k) as a practical example to illustrate FDA submission requirements. - [Off-The-Shelf Software: Best Practices, FAQs, and Examples](https://innolitics.com/articles/off-the-shelf-software-best-practices-faqs-and-examples/index.md): An in-depth guide to navigating the use of off-the-shelf software (OTS) in the medical device industry. OTS software is general purpose software you didn’t d... - [Can a Glossary Speed Up Your FDA Review?](https://innolitics.com/articles/can-a-glossary-speed-up-your-fda-review/index.md): Creating a shared glossary is easier said then done. In this article, I explore common pitfalls and propose solutions to creating a clear glossary that can s... - [Can Your Software Diagrams Slow Down Your FDA Submission?](https://innolitics.com/articles/can-your-software-diagrams-slow-down-your-fda-submission/index.md): A short article that attempts to explain why badly made diagrams will confuse FDA reviewers and slow down your submissions. Includes links to the relevant gu... - [How to Write a Medical Device User Manual](https://innolitics.com/articles/how-to-write-a-user-manual/index.md): Need to write a user manual for a medical device? Not sure where to start? This article can give you a place to start - [User Needs vs Requirements](https://innolitics.com/articles/user-needs-vs-requirements/index.md): What is the difference between user needs and requirements? - [Draft FDA Generative AI Guidance](https://innolitics.com/articles/april-fools-joke-2024/index.md): April Fools 2023 Joke: New FDA AI/ML Draft Guidance: Recommendations and Risk Assessment of Generative (AI/ML)-Enabled Quality Management and Premarket Submi... - [How to Avoid $100k AI/ML Mistake](https://innolitics.com/articles/how-to-avoid-k-ai-ml-mistake/index.md): Learn how to avoid invalidating your test dataset while still allowing yourself some flexibility to re-use the test data. - [To Rewrite or Not: From Prototype to FDA-Compliant Software](https://innolitics.com/articles/to-rewrite-or-not-from-prototype-to-fda-compliant-software/index.md): This article discusses engineering and regulatory factors to consider when deciding to rewrite or reuse existing prototype code. It should be useful to resea... - [Future of Generative AI in Software Medical Devices](https://innolitics.com/articles/future-of-generative-ai-in-software-medical-devices/index.md): This video discusses the potential avenues for getting generative AI applications cleared through FDA. - [AI/ML from Idea to FDA](https://innolitics.com/articles/ai-ml-from-idea-to-fda-p1/index.md): This article outlines the process of developing an AI/ML algorithm from scratch and getting it FDA cleared. It covers the four phases of the process (Explore... - [Digital Therapeutics: Best Practices, FAQs, and Examples](https://innolitics.com/articles/digital-therapeutics-best-practices-faqs-and-examples/index.md): An overview of best practices and regulatory strategies related to digital therapeutics. - [Medical-Device Software Regulations: Best Practices, FAQs, and Examples](https://innolitics.com/articles/medical-device-software-regulations-best-practices-faqs-and-examples/index.md): A comprehensive FAQ for people who are interested in creating a new medical device software to learn the basics about the US regulations. - [Why Are you Wasting Time Building Your Medical Device?](https://innolitics.com/articles/why-are-you-wasting-time-building-your-medical-device/index.md): If you’ve ever been working on a medical-device and have thought, “this is a waste of time,” this article is for you. It will provide a framework for underst... - [FDA Webinar Notes: Predicate Device Selection and Use of Clinical Data](https://innolitics.com/articles/fda-webinar-notes-predicate-device-selection-and-use-of-clinical-data/index.md): This article provides an overview of FDA’s webinar regarding a set of guidance documents that were recently released by FDA as a continued effort to moderniz... - [2023 Final FDA Cybersecurity Guidance - Redline](https://innolitics.com/articles/final-fda-cybersecurity-guidance-redline/index.md): This is a redline between the 2022 Draft cybersecurity guidance and the final 2023 cybersecurity guidance. It should be useful to medical-device regulatory p... - [How Frequently Can you Release Medical Device Software?](https://innolitics.com/articles/how-frequently-can-you-release-medical-device-software/index.md): Medical-device software release frequency is a common question, particularly from software engineers familiar with agile development. The answer hinges on tw... - [2023 FDA Guidance - Off-The-Shelf Software Use in Medical Devices](https://innolitics.com/articles/2023-ots-software-guidance/index.md): This guidance document explains how medical device manufacturers can incorporate off-the-shelf software (OTS) into their devices, while still ensuring contin... - [Algorithm Performance Testing Intake Form](https://innolitics.com/articles/algorithm-performance-testing-intake-form/index.md): This article provides a questionnaire for those looking to get their AI algorithm FDA cleared. It covers topics such as validation studies, non-ML and ML sof... - [Get to Market Faster with Software-Savvy Regulatory Experts](https://innolitics.com/articles/get-to-market-faster-with-software-savvy-regulatory-experts/index.md): This article explains why regulatory consultants who understand software can save your engineers time and help get your medical device to market faster. It a... - [“It’s the Workflow, Stupid” - Lessons Learned Bringing Radiology AI/ML to Market](https://innolitics.com/articles/its-the-workflow-stupid-and-other-ai-lessons/index.md): This article outlines the challenges of bringing radiology AI/ML to market, from clinical workflow to IT installation. It provides insights and lessons learn... - [2023 FDA Guidance - Content of Premarket Submissions for Device Software Functions](https://innolitics.com/articles/fda-guidance-content-of-premarket-submissions-for-device-software-functions/index.md): Describes all of the documents you need to include in 510(k) submissions for medical devices containing software functions. It’s the first big update since 2... - [Multiple Device Functions Impact on FDA Submissions](https://innolitics.com/articles/multiple-device-functions/index.md): A distillation of the 27 page FDA guidance document ‘Multiple Function Device Products: Policy and Considerations’. - [eSTAR Version 3 Transcript (Non-IVD Version)](https://innolitics.com/articles/estar-version-transcript-non-ivd-version/index.md): About this eSTAR TranscriptThe electronic Standard Technical Application (eSTAR) is a complete regulatory framework meant to accelerate and harmonize the med... - [2023 FDA Guidance - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program](https://innolitics.com/articles/2023-q-sub-guidance/index.md): This guidance discusses the FDA’s Q-Submission program, which can be used to get feedback on your predicate device selection, performance study design, cyber... - [2023 FDA Draft Guidance - Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions](https://innolitics.com/articles/fda-draft-pccp-guidance/index.md): FDA's Draft PCCP (Predetermined Change Control Plan) guidance should streamline model changes AI/ML-enabled devices, allowing for pre-approved modifications ... - [Webinar on AI/ML from Idea to FDA](https://innolitics.com/articles/webinar-on-ai-ml-from-idea-to-fda/index.md): This webinar covers the four phases of the regulatory process: Explore, Develop, Validate, and Document. It also discusses the costs, time, and data requirem... - [Powerful Debugging Techniques: A Real-World Example](https://innolitics.com/articles/powerful-debugging-techniques-a-real-world-example/index.md): Learn from a real-world MedTech OS software bug and explore various debugging techniques that can help you navigate through software issues and find solution... - [Can We Work on our SaMD After Submitting our 510(k)?](https://innolitics.com/articles/can-we-work-on-our-samd-after-submitting-our-k/index.md): We talk through a strategy for speeding up 510(k) submissions by using a letter to file for certain features that wouldn't trigger the need for another 510(k). - [Why Notion is the Best Traceability Tool for Medical Device Startups](https://innolitics.com/articles/why-notion-is-the-best-traceability-tool-for-medical-device-startups/index.md): What is traceability? How does Notion help you handle it? How does Notion's flexibility empower medical device startups in ways that eQMS vendors can't. - [Quick Introduction to User Needs and Requirements](https://innolitics.com/articles/quick-introduction-to-user-needs-and-requirements/index.md): A quick introduction to writing user needs and requirements for a medical device. - [How to Grow a 10x Team with Code Reviews](https://innolitics.com/articles/how-to-grow-a-x-team-with-code-reviews/index.md): This video explains why code reviews are essential for growing a 10x software engineering team and how to do code reviews well. - [2022 FDA Guidance - Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions](https://innolitics.com/articles/2022-responding-to-deficiences-guidance/index.md): This FDA guidance document provides advice for making deficiency requests for medical device marketing applications in accordance with the Least Burdensome P... - [2022 FDA Guidance - Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in - Premarket Notification (510(k)) Submissions](https://innolitics.com/articles/fda-guidance-radiology-cad-clinical-performance/index.md): This FDA guidance applies to AI/ML-enabled radiology software that assists in the detection of disease. Many of the principles and approaches, however, apply... - [2022 FDA Guidance - Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions](https://innolitics.com/articles/fda-guidance-computer-assisted-detection-devices-applied-to-radiology-images-and-radiology-device-data-premarket-notification-k-submissions/index.md): This guidance is describes FDA’s thoughts on evaluating the performance of CADe radiological devices. Designing standalone and clinical performance testing s... - [2022 FDA Guidance - Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices](https://innolitics.com/articles/2022-medical-device-data-systems-guidance/index.md): This FDA guidance document outlines the policy for medical device data systems, medical image storage devices, and medical image communications devices. It e... - [2022 FDA Guidance - Technical Performance Assessment of Quantitative Imaging in Device Premarket Submissions](https://innolitics.com/articles/2022-assessment-of-quantitative-imaging-guidance/index.md): This document outlines the technical performance assessment required for premarket submissions of quantitative imaging devices to the FDA. It provides guidan... - [IMDRF 2022 Guidance - Machine Learning-enabled Medical Devices: Key Terms and Definitions](https://innolitics.com/articles/imdrf-guidance-machine-learning-enabled-medical-devices-key-terms-and-definitions/index.md): Introduces standardized terms and definitions to foster a consistent understanding across the industry for ML-enabled devices. - [2021 FDA Guidance - De Novo Classification Process](https://innolitics.com/articles/fda-guidance-de-novo-classification-process/index.md): Explains how to request classification into Class I or II through the De Novo pathway, providing a streamlined alternative to the PMA process. It's particula... - [Fuzzing, Sanitizers, and Modern Cybersecurity Practices](https://innolitics.com/articles/fuzzing-sanitizers-and-modern-cybersecurity-practices/index.md): Security vulnerabilities in medical devices can have devestating consequences. They can lead to patient injuries and in the worst cases, death. In our first ... - [How We Develop AI for 510(k)-Cleared Devices](https://innolitics.com/articles/machine-learning-development-for-medical-devices/index.md): This article outlines Innolitics' process for developing machine learning algorithms for FDA-cleared medical devices. It covers documentation requirements, c... - [2020 Draft FDA Guidance - Enhancing the Diversity of Clinical Trial Populations — Eligibility Criteria, Enrollment Practices, and Trial Designs Guidance for Industry](https://innolitics.com/articles/draft-fda-guidance-enhancing-clinical-trial-diversity/index.md): This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take t... - [2020 FDA Guidance - Multiple Function Device Products: Policy and Considerations](https://innolitics.com/articles/fda-guidance-multiple-function-device/index.md): This FDA guidance explains the regulatory approach and policy for multiple function device products, which are products that contain at least one device func... - [2020 FDA Guidance Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group of Oncology Therapeutic Products](https://innolitics.com/articles/fda-2020-guidance-ivds-oncology-therapeutic-products/index.md): This guidance applies to in vitro companion diagnostic (CDx) devices intended for use with oncology drugs. It is relevant when a CDx might support the use of... - [2019 FDA Guidance - Acceptance and Filing Reviews for Premarket Approval Applications (PMAs)](https://innolitics.com/articles/fda-2019-guidance-pma-reviews/index.md): Outlines FDA’s criteria for accepting and filing a PMA application. The guidance should help avoid delays, ensures efficient communication with FDA, and supp... - [2019 FDA Guidance - Policy for Device Software Functions and Mobile Medical Applications](https://innolitics.com/articles/fda-guidance-policy-for-device-software-functions-and-mobile-medical-applications/index.md): This guidance provides crucial information for developers and manufacturers on how the FDA classifies and regulates software functions and mobile apps in the... - [2019 FDA Guidance - General Wellness: Policy for Low Risk Devices](https://innolitics.com/articles/fda-guidance-general-wellness-policy-for-low-risk-devices/index.md): When you’re developing a product that may be a medical device, one of the first questions to ask is: Is it a medical device? Usually this is a straightforwar... - [2019 FDA Guidance - The Special 510(k) Program](https://innolitics.com/articles/fda-guidance-the-special-k-program/index.md): The Special 510(k) is an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device. This g... - [2019 FDA Guidance - The Abbreviated 510(k) Program](https://innolitics.com/articles/fda-guidance-the-abbreviated-k-program/index.md): This guidance describes the abbreviated 510(k) program, which may be chosen when the device can be validated with FDA guidance document(s), demonstration of ... - [2019 FDA Guidance - Format for Traditional and Abbreviated 510(k)s](https://innolitics.com/articles/fda-guidance-format-for-traditional-and-abbreviated-k-s/index.md): This FDA guidance document provides a general framework for formatting and content of Traditional or Abbreviated 510(k) submissions. The document explains ea... - [2019 FDA Guidance - Factors to Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications](https://innolitics.com/articles/fda-benefit-risk-premarket-devices/index.md): Applies to entities that service or modify medical devices and helps determine when those activities qualify as “remanufacturing” under FDA regulations. It o... - [2019 FDA Guidance - The Least Burdensome Provisions: Concept and Principles](https://innolitics.com/articles/fda-guidance-least-burdensome-approach-2019/index.md): The FDA guidance on the least burdensome approach—the minimum amount of information necessary to adequately address a relevant regulatory question or issue t... - [2018 FDA Guidance - Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices](https://innolitics.com/articles/fda-guidance-appropriate-use-of-voluntary-consensus-standards-in-premarket-submissions-for-medical-devices/index.md): This FDA guidance explains the relationship between standards and regulations and how to properly declare conformance to standards. It also covers how to han... - [2018 FDA Guidance - Medical Product Communications That Are Consistent With the FDA-Required Labeling Questions and Answers](https://innolitics.com/articles/fda-guidance-medical-product-communications-that-are-consistent-with-the-fda-required-labeling-questions-and-answers/index.md): This FDA guidance provides context regarding device labeling. Labeling, which includes advertising, is important to consider early in the development of a ne... - [2017 FDA Guidance - Medical Device Accessories – Describing Accessories and Classification Pathways](https://innolitics.com/articles/fda-guidance-medical-device-accessories/index.md): This FDA guidance document describes the regulation of medical device accessories and provides guidance on how accessories are classified and regulated under... - [2017 FDA Guidance - Software as a Medical Device (SAMD): Clinical Evaluation](https://innolitics.com/articles/fda-guidance-software-as-a-medical-device-samd-clinical-evaluation/index.md): This document details the necessary processes for assessing the safety, effectiveness, and performance of SAMD, including the stages of clinical evaluation, ... - [2017 FDA Guidance - Deciding When to Submit a 510(k) for a Software Change to an Existing Device](https://innolitics.com/articles/fda-guidance-deciding-when-to-submit-a-k-for-a-software-change-to-an-existing-device/index.md): This FDA guidance document provides manufacturers of medical devices with information on when a new premarket notification (510(k)) is required for a softwar... - [2017 FDA Guidance - Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies. Guidance for Industry and Food and Drug Administration Staff](https://innolitics.com/articles/fda-guidance-demographic-data-medical-devices/index.md): Applies when designing and submitting clinical studies for medical devices, especially those seeking FDA approval or clearance. It highlights the importance ... - [2017 FDA Guidance - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices](https://innolitics.com/articles/interoperability-guidance/index.md): The FDA guidance discussing risks and documentation for pre-market submissions when devices must inter-operate with other devices (e.g., via DICOM or other s... - [2016 FDA Guidance - Postmarket Management of Cybersecurity in Medical Devices](https://innolitics.com/articles/fda-guidance-postmarket-management-of-cybersecurity-in-medical-devices/index.md): This FDA guidance outlines recommendations for managing cybersecurity vulnerabilities in medical devices, including a risk-based framework for assessing when... - [2016 FDA Guidance - Factors to Consider Regarding Benefit-Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions](https://innolitics.com/articles/fda-guidance-factors-to-consider-regarding-benefit-risk-in-medical-device-product-availability-compliance-and-enforcement-decisions/index.md): This document provides guidance for the FDA staff and medical device industry on how to navigate the benefit and risk factors when making product availabilit... - [2016 FDA Guidance - Collection of Race and Ethnicity Data in Clinical Trials](https://innolitics.com/articles/fda-2016-guidance-race-and-ethnicity-data-in-clinical-trials/index.md): Applies to clinical trials supporting FDA applications for drugs, biologics, and devices. It standardizes how race and ethnicity data should be collected and... - [2016 FDA Guidance - Applying Human Factors and Usability Engineering to Medical Devices](https://innolitics.com/articles/fda-guidance-applying-human-factors/index.md): This FDA guidance document provides recommendations for medical device manufacturers to minimize potential use errors and resulting harm through the use of h... - [2014 FDA Guidance - Evaluation of Sex-Specific Data in Medical Device Clinical Studies. Guidance for Industry and Food and Drug Administration Staff](https://innolitics.com/articles/fda-guidance-sex-specific-data-medical-devices/index.md): Relevant to sponsors of medical device clinical studies, this guidance emphasizes the importance of analyzing and reporting data by sex. It impacts study des... - [2014 FDA Guidance - In Vitro Companion Diagnostic Devices](https://innolitics.com/articles/fda-guidance-in-vitro-companion-diagnostic-devices/index.md): Applies to companies developing diagnostic tests that guide the safe and effective use of a corresponding therapeutic product. It clarifies regulatory expect... - [2014 FDA Guidance - The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications](https://innolitics.com/articles/fda-guidance-the-k-program/index.md): This FDA guidance for industry and FDA staff about the current review practices for premarket notification (510(k)) submissions, and identifies, explains, an... - [2014 FDA Guidance - Types of Communication During the Review of Medical Device Submissions](https://innolitics.com/articles/fda-guidance-types-of-communication-during-the-review-of-medical-device-submissions/index.md): This FDA guidance document describes the types of communication that occur during the review of medical device submissions. It explains the four types of com... - [2013 FDA Guidance - Design Considerations for Pivotal Clinical Investigations for Medical Devices](https://innolitics.com/articles/fda-guidance-design-considerations-for-pivotal-clinical-investigations-for-medical-devices/index.md): The FDA guidance regarding Design Considerations for Pivotal Clinical Investigations for Medical Devices. - [2013 FDA Guidance - Medical Device Classification Product Codes](https://innolitics.com/articles/fda-guidance-medical-device-classification/index.md): This document provides information on how device product codes are used in various FDA program areas to regulate and track medical devices regulated by the C... - [2007 FDA Guidance - Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests](https://innolitics.com/articles/fda-guidance-statistical-guidance-on-reporting-results-from-studies-evaluating-diagnostic-tests/index.md): Provides essential recommendations for presenting results from studies evaluating diagnostic devices. It covers qualitative diagnostic tests' reporting in pr... - [2005 FDA Guidance - Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software](https://innolitics.com/articles/fda-guidance-cybersecurity-for-networked-medical-devices/index.md): This FDA guidance outlines how manufacturers should maintain the cybersecurity of medical devices that use off-the-shelf software. The guidance provides gene... - [2002 FDA Guidance - General Principles of Software Validation](https://innolitics.com/articles/fda-guidance-general-principles-of-software-validation/index.md): This FDA guidance outlines general validation principles that are applicable to the validation of medical device software or the validation of software used ... - [2001 FDA Guidance - Medical Device Patient Labeling](https://innolitics.com/articles/fda-guidance-medical-device-patient-labeling/index.md): This guidance serves to assist manufacturers in their development, and to assist Center reviewers in their review and evaluation of medical device patient la... - [1997 FDA Guidance - Design Control Guidance for Medical Device Manufacturers](https://innolitics.com/articles/fda-guidance-design-control-guidance/index.md): The big old FDA Design Controls guidance from 1997, transcribed into a linkable HTML document. ## Topics - [AI/ML Articles & Videos](https://innolitics.com/articles/ai-ml/index.md): Regulatory strategy for AI/ML-enabled devices, training and validation best-practices, pre-sub questions, and more - 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David Giese](https://innolitics.com/people/j-david-giese/index.md): Partner - [Jennifer Dixon](https://innolitics.com/people/jennifer-dixon/index.md): Senior Regulatory Affairs Specialist - [Juan Pablo Centeno](https://innolitics.com/people/juan-pablo-centeno/index.md): Senior Software Engineer II - [Kris Huang](https://innolitics.com/people/kris-huang/index.md): Physician Engineer - [Maddie Tran](https://innolitics.com/people/maddie-tran/index.md): Associate Quality/Regulatory Consultant - [Mary Vater](https://innolitics.com/people/mary-vater/index.md): Director of Regulatory Affairs - [Matt Hancock](https://innolitics.com/people/matt-hancock/index.md): Senior Software Engineer II - [Meri Martinez](https://innolitics.com/people/meri-martinez/index.md): Senior Regulatory Affairs Specialist - [Michael Millan](https://innolitics.com/people/michael-millan/index.md): Senior Software Engineer I - [Mihajlo Grčić](https://innolitics.com/people/mihajlo-grcic/index.md): Director of Admin/Finance - [Nicholas Chavez](https://innolitics.com/people/nicholas-chavez/index.md): Senior Software Engineer I - [Quinten Sodia](https://innolitics.com/people/quinten-sodia/index.md): Senior Software Engineer I - [Reece Stevens](https://innolitics.com/people/reece-stevens/index.md): Director of Engineering - [Shaily Shah](https://innolitics.com/people/shaily-shah/index.md): Senior Regulatory Affairs Specialist - [Valeriia Zakrasniana](https://innolitics.com/people/valeriia-zakrasniana/index.md): Admin Assistant - [Vineel Bhattiprolu](https://innolitics.com/people/vineel-bhattiprolu/index.md): Intern Engineer - [Yujan Shrestha](https://innolitics.com/people/yujan-shrestha/index.md): Partner ## Job Openings - [Admin Assistant](https://innolitics.com/join/admin-assistant/index.md) - [Associate QA/RA Consultant](https://innolitics.com/join/associate-qa-ra-consultant/index.md) - [Associate QA/RA Consultant & Project Manager](https://innolitics.com/join/associate-qa-ra-consultant-&-project-manager/index.md) - [Associate QA/RA Consultant & Project Manager](https://innolitics.com/join/associate-qa-ra-consultant--project-manager/index.md) - [Associate QA/RA Consultant & Project Manager](https://innolitics.com/join/associate-qara-consultant--project-manager/index.md) - [Associate Regulatory Writer & Project Manager](https://innolitics.com/join/associate-regulatory-writer-&-project-manager/index.md) - [Associate Regulatory Writer & Project Manager](https://innolitics.com/join/associate-regulatory-writer--project-manager/index.md) - [Business Development Representative](https://innolitics.com/join/business-development-representative/index.md) - [Hiring a Medical Device Software Engineer](https://innolitics.com/join/hiring-a-medical-device-software-engineer/index.md) - [Marketing Manager](https://innolitics.com/join/marketing-manager/index.md) - [Medical Device AI/ML Engineer](https://innolitics.com/join/medical-device-ai-ml-engineer/index.md) - [Medical Device Software Engineer](https://innolitics.com/join/medical-device-software-engineer/index.md) - [Physician-Scientist (MD or equivalent) – Biostatistics & ML Development for Medical Device AI](https://innolitics.com/join/physician-scientist-md-or-equivalent--biostatistics--ml-development-for-medical-device-ai/index.md) - [Senior Cybersecurity Engineer](https://innolitics.com/join/senior-cybersecurity-engineer/index.md) - [Senior Marketing Manager, Demand Generation & Content](https://innolitics.com/join/senior-marketing-manager-demand-generation--content/index.md) - [Senior Regulatory Affairs Specialist AI/ML SaMD](https://innolitics.com/join/senior-regulatory-affairs-specialist-ai-ml-samd/index.md) - [Senior Web/Mobile Medical Device Engineer](https://innolitics.com/join/senior-web-mobile-medical-device-engineer/index.md) - [Technical Project Manager](https://innolitics.com/join/technical-project-manager/index.md) ## Landing Pages - [End-to-End FDA Clearance for SaMD | Data In, Cleared Device Out | Innolitics](https://innolitics.com/services/end-to-end-fda-clearance/index.md): Hand us the clinical data and the regulatory goal. We handle the engineering, AI/ML, QMS, V&V, cybersecurity, and submission. One team, one timeline, one... - [The FDA Software Partner Pharma Leaders Pick | Innolitics](https://innolitics.com/pharma-software-enablement/index.md): Petros Pharmaceuticals picked Innolitics. When pharma teams need ACNU switches, companion diagnostics, qualified imaging endpoints, MDDTs, or validated clini...