Medical device software articles, videos, and guidance from Innolitics.
FeaturedArticleRegulatory
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 offers insider tips on ...
J. David Giese
FeaturedArticleAI/ML
The myth: a real-time or in-procedure indication needs a hardware device. We screened all 1,483 AI/ML-flagged FDA records and found 50 verified clearances where software-only de...
Yujan Shrestha
FeaturedArticleAI/ML
FDA selected Limbic’s agentic therapy device for the TEMPO pilot. Its public evidence offers a rare look at layered AI architecture, prospective clinical testing, post-market mo...
J. David Giese
FeaturedArticleCybersecurity
This article provides an in-depth exploration of medical device cybersecurity requirements, including best practices and FAQs. It also includes examples and resources for those ...
J. David Giese
FeaturedArticleRegulatory
The question we hear most from AI-SaMD teams. How FDA's device definition and the five statutory carve-outs actually apply, why the call is harder than it looks, why competitors...
J. David Giese
FeaturedArticleRegulatory
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 regulatory risk. This ...
J. David Giese
FeaturedArticleAI/ML
FDA's Aug 18, 2026 discussion paper proposes grading generative AI medical devices like physicians: benchmarks, then clinical confirmation, then live monitoring. What it says, w...
Yujan Shrestha
FeaturedArticleAI/ML
Most diagnostic AI teams clear FDA, then stall on reimbursement. FDA's TEMPO pilot and CMS's ACCESS model take on evidence and payment together. Here's how the two work, and wha...
J. David Giese
FeaturedArticleAI/ML
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 consulting judgment, and ...
Yujan Shrestha
FeaturedArticleAI/ML
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 route choices that c...
Yujan Shrestha
FeaturedArticleAI/ML
FDA's draft MDUFA VI commitment letter (FY2028–2032) restructures how sponsors interact with the agency. Seven changes that will reshape submission planning for software and AI ...
Yujan Shrestha
FeaturedArticleAI/ML
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 behind a determinis...
Yujan Shrestha
FeaturedArticleAI/ML
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 capital-efficient, 2...
Yujan Shrestha
FeaturedArticleAI/ML
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 (DEN240068), Galen S...
Maddie Tran & Yujan Shrestha
FeaturedArticleAI/ML
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 clearances shows $51.2M ...
Yujan Shrestha
FeaturedArticleAI/ML
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 under-adoption, the lo...
Yujan Shrestha
FeaturedArticleAI/ML
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 fine-tuning, built on...
Yujan Shrestha
FeaturedArticleAI/ML
Fifty-one FDA-authorized pathology AI devices through April 2026, only seven of which are whole-slide imaging algorithms. This snapshot separates the hematology-analyzer volume ...
Yujan Shrestha
FeaturedArticleAI/ML
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-cleared software.
Yujan Shrestha
FeaturedArticleAI/ML
Why digital health companies keep dying before and after FDA authorization, the evidence-reimbursement trap strangling the sector, and a post-market-first framework for breaking...
Yujan Shrestha
FeaturedArticleAI/ML
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.
Yujan Shrestha
FeaturedArticleAI/ML
Comprehensive analysis of 2025 cardiology AI/ML clearances, market trends, capital events, and regulatory insights.
Yujan Shrestha
FeaturedArticleRegulatory
Side by side differences and executive takeaways from the January 2026 updates to the FDA CDS and General Wellness updates
Yujan Shrestha
FeaturedArticleAI/ML
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 market, the 172-day FD...
Yujan Shrestha
FeaturedArticleAI/ML
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.
Yujan Shrestha
FeaturedArticleAI/ML
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 to get foundation mo...
Yujan Shrestha
FeaturedArticleAI/ML
Breakthrough Device Designation (BDD) is a free, fast FDA program that signals serious unmet need and potential meaningful improvement. For AI/ML SaMD teams, it de-risks pivotal...
Yujan Shrestha & George Hattub
FeaturedArticleAI/ML
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 medical device clearance...
Yujan Shrestha
FeaturedArticleAI/ML
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 standalone evidence thro...
Yujan Shrestha
FeaturedArticleAI/ML
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.
Yujan Shrestha
FeaturedArticleAI/ML
A practical guide for engineers new to medical imaging AI, highlighting common pitfalls—like coordinate-system errors and orientation mix-ups—and providing simple checks to avoi...
Yujan Shrestha
FeaturedArticleRegulatory
The FDA says developing your design inputs is “the single most important design control activity,” yet writing good design inputs is difficult. This article presents Innolitics’...
J. David Giese
FeaturedArticleRegulatory
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 offers insider tips on ...
J. David Giese
FeaturedArticleCybersecurity
Practical suggestions and tips for authoring SBOMs for medical devices and for using them to monitor for cybersecurity vulnerabilities.
J. David Giese
FeaturedArticleAI/ML
Ideas on how to get foundation models and generative AI FDA cleared.
Yujan Shrestha
FeaturedArticleAI/ML
Recent advancements in radiology have led to the development of foundation models integrating vision and language capabilities, transforming medical imaging analysis
Yujan Shrestha
FeaturedArticleRegulatory
A comprehensive FAQ for people who are interested in creating a new medical device software to learn the basics about the US regulations.
J. David Giese
ArticleAI/ML
Plan HD95 acceptance criteria and sample size for medical image segmentation with an interactive calculator, tested Python, and a 250 patient budget example.
Yujan Shrestha & Nishant Dahal
ArticleAI/ML
We traced every AI SaMD De Novo's predicate descendants and found prospective enrollment falling toward zero by the third generation. Where you sit on your category's generation...
Yujan Shrestha
ArticleAI/ML
For founders and CFOs sizing the team a first AI SaMD submission needs. A census of 890 FDA clearance letters for AI software devices, a 24-company cohort with headcounts and re...
Yujan Shrestha
ArticleAI/ML
The myth: your 510(k) predicate must match your body region, modality, and product code. We screened all 1,457 AI/ML-flagged FDA records across six axes of predicate distance an...
Yujan Shrestha
ArticleAI/ML
If your protocol says 250 patients, the first reviewer question is: 250 what? Sensitivity is powered by condition-positive cases and specificity by negatives, so plan each quota...
Yujan Shrestha & Nishant Dahal
ArticleAI/ML
There is no single sample size for passing AUC 0.90. The pass rule, expected AUC, confidence interval method, and class mix set the number together. A worked 0.93 example lands ...
Yujan Shrestha & Nishant Dahal
ArticleAI/ML
FDA has selected Cadence as the second participant in TEMPO. Its clinician-supervised HypertensionOS software generates protocol-bound medication-initiation and titration propos...
J. David Giese
ArticleAI/ML
With predetermined change control plans (PCCPs), FDA has given manufacturers a great new regulatory tool. In this article, we discuss PCCP best practices and questions based on ...
J. David Giese
ArticleAI/ML
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 them with AI, and mappe...
Yujan Shrestha
ArticleAI/ML
CMS and CDC are asking whether AI-assisted postanalytic interpretation, digital pathology, cloud analytics, and data-only medical-device software facilities should fall within t...
Yujan Shrestha
ArticleRegulatory
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 examples, and commit the...
Yujan Shrestha
ArticleAI/ML
Learn how to write an FDA-ready AI model description covering inputs, outputs, architecture, training, selection, thresholds, pretrained components, limitations, and the submitt...
Yujan Shrestha
ArticleSoftware
Notes on medtech funding, covering accelerators and funding sources.
J. David Giese
ArticleAI/ML
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-processing AI, and PCCP...
Yujan Shrestha
ArticleAI/ML
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-day review: a new S...
Yujan Shrestha
ArticleAI/ML
From solo clinicians prototyping algorithms to enterprise teams shipping production software, tools like Cursor, Claude Code, ChatGPT Codex, GitHub Copilot, Lovable, Replit, Ant...
Yujan Shrestha
ArticleNews
A reflection on how Innolitics revisits its mission and values at the annual retreat—and why that exercise sharpens judgment, strengthens alignment, and deepens team ownership.
J. David Giese
ArticleCybersecurity
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 deposits.
J. David Giese
ArticleAI/ML
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 companies, and why the com...
Yujan Shrestha
ArticleAI/ML
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 bootstrap confidence...
Yujan Shrestha & Nishant Dahal
GuidanceCybersecurity
The 2026 FDA guidance on medical device cybersecurity, updated to align cybersecurity expectations with the Quality Management System Regulation (QMSR) and ISO 13485.
GuidanceAI/ML
This FDA guidance clarifies which clinical decision support (CDS) software functions are excluded from the definition of a medical device.
Valeriia Zakrasniana
ArticleAI/ML
Yujans commentary on the new Non-invasive blood pressure measuring device FDA guidance document in response to WHOOP and others.
Yujan Shrestha
ArticleAI/ML
A deep dive into K232613 (CT Cardiomegaly)
Yujan Shrestha
ArticleAI/ML
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 Lumosity’s digital thera...
Yujan Shrestha
Article
Diabeloop’s DBLG2 clearance proves high-risk SaMD viability, demonstrating how decoupling software from hardware minimizes regulatory burden.
Yujan Shrestha
ArticleRegulatory
Are your medical device timelines slipping despite a smart team and lots of effort? This article explains Innolitics’ practical, Gantt-chart-driven approach to medical device pr...
J. David Giese
ArticleAI/ML
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 regulated AI momentum.
Yujan Shrestha
ArticleAI/ML
Analysis of K252086 (DTX Studio Assist), a strategic 510(k) clearance for a 'headless' SDK. This submission minimizes regulatory burden by offloading UI requirements, employs a ...
Yujan Shrestha
GuidanceRegulatory
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 relevant and reliable...
Valeriia Zakrasniana
ArticleAI/ML
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 to anchor on constra...
Yujan Shrestha
ArticleAI/ML
This article explains Bland–Altman analysis for evaluating agreement between two continuous measurement methods, especially in FDA-facing validation. It shows how bias and 95% l...
Yujan Shrestha
Article
Practical tips on how to structure your SaMD architecture for FDA review without mirroring your codebase. Explains what the FDA means by “system/software items,” how to use mult...
Meri Martinez & Yujan Shrestha
Article
A “quick” reference guide grouping the example 510(k) clearances by their product code/regulation, summarizing required testing and the rationale behind it.
Meri Martinez
ArticleAI/ML
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) (Body Check CT Cardio...
Yujan Shrestha
ArticleRegulatory
An FAQ regarding the FDA’s new ACNU Rule.
J. David Giese
ArticleRegulatory
The “Unresolved Anomalies” document is required for the FDA’s pre-market submissions. This article includes best practices, FAQs, and examples for writing this document.
J. David Giese
ArticleRegulatory
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 is, who qualifies, an...
J. David Giese
ArticleAI/ML
Command Line as a Medical Device (CLaMD) represents a streamlined approach to FDA clearance for medical software. By utilizing command-line interfaces instead of graphical user ...
Yujan Shrestha
ArticleRegulatory
To provide quality service to our clients, we need to do more than produce quality work.
J. David Giese
ArticleCybersecurity
In this article, we share a nuanced approach to avoiding sharing sensitive information in an SBOM.
J. David Giese
GuidanceRegulatory
This guidance applies to sponsors designing or submitting clinical studies for medical devices. It highlights the importance of including and analyzing sex-specific data to ensu...
Valeriia Zakrasniana
VideoRegulatory
The discussion in the transcript revolves around the FDA’s Draft Guidance on AI in Medical Devices, focusing on regulatory considerations, cybersecurity threats, risk mitigation...
Matt Hancock
VideoAI/ML
Kris Huang led a discussion on key image processing techniques in medical imaging, focusing on CT and MRI scans. Topics included histogram equalization, morphological operations...
Kris Huang
GuidanceRegulatory
Applicable to sponsors submitting PMAs for medical devices and offers a flexible, staged approach to review. By allowing earlier feedback on individual modules, it can accelerat...
Valeriia Zakrasniana
GuidanceRegulatory
Applies to manufacturers of AI-enabled medical devices and outlines expectations for managing changes to AI software across its lifecycle. It provides recommendations for market...
VideoRegulatory
A panel discussion about the FDA's Predetermined Change Control Plan (PCCP) guidance, particularly its application to AI-enabled medical devices. The conversation includes panel...
Yujan Shrestha & 2 others
VideoAI/ML
The document details the process and significance of Clinical Performance Assessments (CPAs) for medical devices, focusing on their role in regulatory approval. It highlights th...
Ethan Ulrich
VideoAI/ML
Discussion covered key takeaways from the RSNA conference, balancing safety with speed, and setting risk thresholds. Topics included statistical power, U.S. data needs, AI/ML sa...
Yujan Shrestha & 2 others
VideoSoftware
The discussion outlines the evolution of FDA regulations, common violations, and the enforcement structure. It emphasizes the importance of compliance in medical device manufact...
George Hattub
VideoAI/ML
This is a recording of the talk Yujan gave at the RSNA AI Theater
Yujan Shrestha
Video
The growing role of AI in regulatory affairs, emphasizing its potential to enhance efficiency while requiring careful oversight. Challenges like resistance to change and data se...
Yujan Shrestha
Video
Yujan discusses pragmatic postmarket surveillance to FDA advisory committee on GenAI
Yujan Shrestha
VideoAI/ML
The discussion explores generative AI (GenAI) in medical devices, focusing on FDA's considerations for regulation, risks, and the lifecycle management of such technologies. Key ...
Yujan Shrestha & J. David Giese
VideoCybersecurity
The conversation between Yujan Shrestha and J. David Giese focuses on making threat modeling more approachable and less intimidating. They share personal anecdotes to illustrate...
Yujan Shrestha & J. David Giese
VideoAI/ML
Dr. Elena Sizikova's presentation highlights the role of synthetic data in addressing data scarcity and privacy challenges in medical imaging AI. Synthetic data offers benefits ...
Yujan Shrestha
VideoCybersecurity
We discuss challenges in medical device cybersecurity, including balancing FDA guidelines with practical hospital and manufacturer needs. They highlight risks like network vulne...
Yujan Shrestha & J. David Giese
VideoAI/ML
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 risk analysis, and the...
Yujan Shrestha & J. David Giese
Article
Explores premarket evaluation, risk management, and postmarket monitoring of AI virtual scribes in healthcare, addressing new challenges in transcription accuracy and patient sa...
Yujan Shrestha
VideoAI/ML
A 10x talk exploring the basics of prompt engineering, followed by an open-ended discussion.
VideoAI/ML
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 needed for hardware...
Mary Vater
ArticleDICOM
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.
ArticleRegulatory
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 510(k) submissions ...
Meri Martinez & 2 others
ArticleAI/ML
The article outlines a method for documenting AI/ML algorithms for FDA pre-submissions. It emphasizes clear algorithm descriptions to avoid delays. Key steps include visual runt...
Yujan Shrestha
ArticleCybersecurity
A survey that should give you a feeling as to whether you’re cybersecurity documentation is ready for an FDA marketing submission.
J. David Giese
GuidanceRegulatory
Provides detailed recommendations on implementing Predetermined Change Control Plans (PCCPs), which allow manufacturers to make some pre-defined changes without additional FDA s...
ArticleCybersecurity
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 cybersecurity deficiencies ...
Yujan Shrestha & George Hattub
ArticleSoftware
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 discusses when its an ap...
ArticleAI/ML
Tips and FAQs on how to get a foundation model FDA 510(k) or De Novo cleared.
Yujan Shrestha
ArticleCybersecurity
A technical exploration and discussion of DICOM Part 15 Security
ArticleCybersecurity
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 from ransomware.
ArticleRegulatory
How to Write a Device Description for a 510(k)
ArticleRegulatory
A comprehensive guide to SaMD 510(k) submissions, featuring an unredacted 510(k) as a practical example to illustrate FDA submission requirements.
Yujan Shrestha
ArticleRegulatory
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 develop yourself that...
J. David Giese
ArticleRegulatory
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 speed up your submiss...
J. David Giese
ArticleCybersecurity
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 guidance and a few bes...
J. David Giese
ArticleRegulatory
Need to write a user manual for a medical device? Not sure where to start? This article can give you a place to start
Yujan Shrestha
ArticleAI/ML
What is the difference between user needs and requirements?
Yujan Shrestha
ArticleNews
April Fools 2023 Joke: New FDA AI/ML Draft Guidance: Recommendations and Risk Assessment of Generative (AI/ML)-Enabled Quality Management and Premarket Submission Review
J. David Giese
ArticleAI/ML
Learn how to avoid invalidating your test dataset while still allowing yourself some flexibility to re-use the test data.
J. David Giese
ArticleRegulatory
This article discusses engineering and regulatory factors to consider when deciding to rewrite or reuse existing prototype code. It should be useful to researchers or companies ...
J. David Giese
VideoAI/ML
This video discusses the potential avenues for getting generative AI applications cleared through FDA.
Yujan Shrestha
ArticleAI/ML
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, Develop, Validate,...
Yujan Shrestha
ArticleRegulatory
An overview of best practices and regulatory strategies related to digital therapeutics.
J. David Giese
ArticleRegulatory
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 understanding which activit...
J. David Giese
ArticleRegulatory
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 modernize the 510(k) process...
Meri Martinez
ArticleCybersecurity
This is a redline between the 2022 Draft cybersecurity guidance and the final 2023 cybersecurity guidance. It should be useful to medical-device regulatory professionals who wan...
J. David Giese & Meri Martinez
ArticleRegulatory
Medical-device software release frequency is a common question, particularly from software engineers familiar with agile development. The answer hinges on two key factors: wheth...
J. David Giese & Jim Luker
GuidanceRegulatory
This guidance document explains how medical device manufacturers can incorporate off-the-shelf software (OTS) into their devices, while still ensuring continued safe and effecti...
ArticleAI/ML
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 software items, and acc...
Yujan Shrestha
ArticleSoftware
This article explains why regulatory consultants who understand software can save your engineers time and help get your medical device to market faster. It also provides tips fo...
J. David Giese
ArticleAI/ML
This article outlines the challenges of bringing radiology AI/ML to market, from clinical workflow to IT installation. It provides insights and lessons learned for those interes...
J. David Giese
GuidanceRegulatory
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 2005 and removes the ...
ArticleRegulatory
A distillation of the 27 page FDA guidance document ‘Multiple Function Device Products: Policy and Considerations’.
GuidanceRegulatory
This guidance discusses the FDA’s Q-Submission program, which can be used to get feedback on your predicate device selection, performance study design, cybersecurity controls, o...
VideoAI/ML
This webinar covers the four phases of the regulatory process: Explore, Develop, Validate, and Document. It also discusses the costs, time, and data requirements involved in the...
Yujan Shrestha
VideoSoftware
Learn from a real-world Medtech OS software bug and explore various debugging techniques that can help you navigate through software issues and find solutions effectively.
J. David Giese
VideoRegulatory
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).
J. David Giese
VideoRegulatory
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).
J. David Giese
VideoRegulatory
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.
J. David Giese
VideoRegulatory
A quick introduction to writing user needs and requirements for a medical device.
J. David Giese
VideoSoftware
This video explains why code reviews are essential for growing a 10x software engineering team and how to do code reviews well.
J. David Giese
GuidanceRegulatory
This FDA guidance document provides advice for making deficiency requests for medical device marketing applications in accordance with the Least Burdensome Provisions. It descri...
GuidanceAI/ML
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 beyond this limited...
GuidanceAI/ML
This guidance is describes FDA’s thoughts on evaluating the performance of CADe radiological devices. Designing standalone and clinical performance testing studies for AI/ML-ena...
GuidanceRegulatory
This FDA guidance document outlines the policy for medical device data systems, medical image storage devices, and medical image communications devices. It explains which softwa...
GuidanceAI/ML
This document outlines the technical performance assessment required for premarket submissions of quantitative imaging devices to the FDA. It provides guidance on the evaluation...
GuidanceAI/ML
Introduces standardized terms and definitions to foster a consistent understanding across the industry for ML-enabled devices.
GuidanceRegulatory
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 particularly relevant for com...
VideoCybersecurity
Security vulnerabilities in medical devices can have devestating consequences. They can lead to patient injuries and in the worst cases, death. In our first public 10x talk, lea...
ArticleAI/ML
This article outlines Innolitics' process for developing machine learning algorithms for FDA-cleared medical devices. It covers documentation requirements, common pitfalls (over...
Yujan Shrestha &
GuidanceRegulatory
This guidance recommends approaches that sponsors of clinical trials intended to support a new drug application or a biologics license application can take to increase enrollmen...
GuidanceRegulatory
This FDA guidance explains the regulatory approach and policy for multiple function device products, which are products that contain at least one device function and at least on...
GuidanceRegulatory
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 multiple approved t...
Valeriia Zakrasniana
GuidanceRegulatory
Outlines FDA’s criteria for accepting and filing a PMA application. The guidance should help avoid delays, ensures efficient communication with FDA, and supports a smoother regu...
Valeriia Zakrasniana
GuidanceRegulatory
This guidance provides crucial information for developers and manufacturers on how the FDA classifies and regulates software functions and mobile apps in the healthcare sector. ...
GuidanceRegulatory
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 straightforward question to answer...
GuidanceRegulatory
The Special 510(k) is an optional pathway for certain well-defined device modifications where a manufacturer modifies its own legally marketed device. This guidance provides FDA...
GuidanceRegulatory
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 compliance with spec...
GuidanceRegulatory
This FDA guidance document provides a general framework for formatting and content of Traditional or Abbreviated 510(k) submissions. The document explains each section of a 510(...
GuidanceRegulatory
Applies to entities that service or modify medical devices and helps determine when those activities qualify as “remanufacturing” under FDA regulations. It outlines key decision...
Valeriia Zakrasniana
GuidanceRegulatory
The FDA guidance on the least burdensome approach—the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most effi...
GuidanceRegulatory
This FDA guidance explains the relationship between standards and regulations and how to properly declare conformance to standards. It also covers how to handle changes in stand...
GuidanceRegulatory
This FDA guidance provides context regarding device labeling. Labeling, which includes advertising, is important to consider early in the development of a new device.
GuidanceRegulatory
This FDA guidance document describes the regulation of medical device accessories and provides guidance on how accessories are classified and regulated under the Federal Food, D...
Guidance
This document details the necessary processes for assessing the safety, effectiveness, and performance of SAMD, including the stages of clinical evaluation, risk management, and...
GuidanceRegulatory
This FDA guidance document provides manufacturers of medical devices with information on when a new premarket notification (510(k)) is required for a software change to an exist...
GuidanceRegulatory
Applies when designing and submitting clinical studies for medical devices, especially those seeking FDA approval or clearance. It highlights the importance of enrolling diverse...
Valeriia Zakrasniana
GuidanceCybersecurity
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 standards).
GuidanceCybersecurity
This FDA guidance outlines recommendations for managing cybersecurity vulnerabilities in medical devices, including a risk-based framework for assessing when changes to devices ...
GuidanceRegulatory
This document provides guidance for the FDA staff and medical device industry on how to navigate the benefit and risk factors when making product availability, compliance, and e...
GuidanceRegulatory
Applies to clinical trials supporting FDA applications for drugs, biologics, and devices. It standardizes how race and ethnicity data should be collected and reported, enabling ...
Valeriia Zakrasniana
GuidanceRegulatory
This FDA guidance document provides recommendations for medical device manufacturers to minimize potential use errors and resulting harm through the use of human factors and usa...
GuidanceRegulatory
Applies to companies developing diagnostic tests that guide the safe and effective use of a corresponding therapeutic product. It clarifies regulatory expectations for co-develo...
Valeriia Zakrasniana
GuidanceRegulatory
This FDA guidance for industry and FDA staff about the current review practices for premarket notification (510(k)) submissions, and identifies, explains, and clarifies each of ...
GuidanceRegulatory
This FDA guidance document describes the types of communication that occur during the review of medical device submissions. It explains the four types of communication and provi...
GuidanceRegulatory
The FDA guidance regarding Design Considerations for Pivotal Clinical Investigations for Medical Devices.
GuidanceRegulatory
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 Center for Devices an...
GuidanceRegulatory
Provides essential recommendations for presenting results from studies evaluating diagnostic devices. It covers qualitative diagnostic tests' reporting in premarket approval and...
GuidanceCybersecurity
This FDA guidance outlines how manufacturers should maintain the cybersecurity of medical devices that use off-the-shelf software. The guidance provides general principles for s...
GuidanceRegulatory
This FDA guidance outlines general validation principles that are applicable to the validation of medical device software or the validation of software used to design, develop, ...
J. David Giese
GuidanceRegulatory
This guidance serves to assist manufacturers in their development, and to assist Center reviewers in their review and evaluation of medical device patient labeling to help make ...
GuidanceRegulatory
The big old FDA Design Controls guidance from 1997, transcribed into a linkable HTML document.
J. David Giese
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