FDA Regulatory Consulting

We are US Regulatory experts who specialize in medical-device AI, software and cybersecurity. We’ve helped over 50 medical-device companies achieve regulatory clearance.

Whether you are looking for a full-service regulatory partner or specialized consulting, we can help.

Let's Meet

Why Choose Us?

All we do is medical-device software
We can bridge the gap between software and regulatory, since we do both
Developed software for over 70 medical devices since 2012
Can handle all of your cybersecurity needs, including threat modeling, security risk management, SBOMs and more

Deep knowledge of medical-device standards, including DICOM and HL7
We can write all the software and cybersecurity documents needed for FDA submissions
Four AI/ML and image-processing experts on our team, including two PhDs
Medtech OS and its checklists, templates, and tooling is built on the experience FDA clearing more than 50 SaMD and SiMD products

Strategic Regulatory Planning and Pre-Submission Expertise

Navigating Compliance and Securing Approval with Precision

Regulatory Strategy and Pre-Subs

For those in the early stages of product development, our team provides strategic guidance to lay a solid regulatory foundation. We understand the unique regulatory challenges of software and leverage our deep industry knowledge to craft bespoke strategies that streamline the path to compliance.

This service may be relevant for you if you’re asking any of the following:

Is my product a medical device?
Will adding certain functionality make our product qualify as a medical device?
What is the fastest way to get your device onto the market?
What are the costs and timelines involved brining a medical device to market?
Our team has experience with hardware devices, but we’re adding software or AI/ML features to our product line.
Which features should we include in our device first? How will certain features affect the regulatory strategy?
We sell our device in Europe already. How can we sell it in the US?
Our product didn’t used to be a device, but the FDA is regulating it—what do we do?

Engaging with the FDA early and effectively is crucial for a smooth regulatory process. We facilitate and manage pre-submission meetings, helping you to clarify and address potential regulatory issues before formal submission.

Let’s Discuss Your Regulatory Strategy

510(k) Submissions

Navigating the 510(k) submission process can be daunting. Our consultants are adept at reviewing and preparing submissions, ensuring that all documentation meets the FDA's rigorous standards.

We provide two services related to 510(k) submissions, depending on your team’s experience and needs.

Our Guided 510(k) Service is for teams who can use support, examples, and review of their 510(k), but generally plan to do most of the documentation work themselves.
Our Fast 510(k) Service is for teams who are in a hurry and see the benefit of shaving off months from their timeline for a premium cost. This is our most unique service offering and it hinges on our combined software and regulatory expertise. We guarantee the results and timeline.

Let’s Discuss Our 510(k) Service

Requests for Additional Information

In the event of additional information requests from regulatory authorities, our team stands ready to assist even if we weren’t involved with the submission. Our Additional Information Request Response Service provides timely and expert support in interpreting and responding to AI Requests, ensuring timely and satisfactory resolutions that keep your project moving forward seamlessly.

Consultation for In-House Teams

We partner with existing regulatory teams to enhance their capabilities, especially in areas where software intersects with medical device regulation. Our experts can fill knowledge gaps around cybersecurity or AI/ML-specific guidance and FDA expectations.

Other Services

De Novo Classification Requests
STEP / Breakthrough Device Designations
513(g) Classification Requests
Second-Opinion US FDA Software Document Review
Second-Opinion US FDA Entire 510(k) against FDA regulations and guidance
Gap assessment of a QMS against IEC 62304, ISO 14971, or ISO 13485
Ongoing Post-Market Regulatory Support

The Clinical Perspective

Our regulatory work is guided by a clinical and software engineering perspective. One of our founders is an MD and we have a broad network of clinicians we leverage. We have experience in the following clinical areas:

Radiology

Digital Health

Radiation Oncology

InVitro Diagnostics (IVDs)

Dental

Cardiology

Pre-Clinical

Ear Nose and Throat

Neurology

Gastroenterology and Urology

What Our Customers Say

During a presubmission meeting, the FDA acknowledged that Innolitics were “extremely advanced” in their understanding of the regulations. The FDA essentially concurred with all of Innolitics’ advice, demonstrating a deep understanding of the regulations, even in the face of ambiguous topics such as CADe vs non-CADe. They expertly, and politely, navigated the FDA call with our best interests in mind while fostering a collaborative exchange with the agency.

Dr. Ilya Pyatnitskiy, MD

Cofounder of AUMI AI

Our FDA submission deadline was just two weeks away, and we had no software or cybersecurity documentation. We feared we would miss the deadline. Then our regulatory team introduced us to Innolitics. Their team swiftly validated our software and prepared the 15 necessary software and cybersecurity documents. They took a pragmatic approach that truly added value. This rapid timeline would have been impossible to meet without a team deeply knowledgeable in software, cybersecurity, AI/ML, and FDA regulations. In the end, we were able to submit on time! Thank you, Innolitics, for your Herculean efforts!

Andrea Cubitt

CEO of Dionysus Digital Health

We’re grateful to Innolitics for their expert help in getting our product 510(k) cleared. Our team was totally focused on other objectives, so we were excited to learn about the Innolitics Fast 510(k) service. Working with them was smooth, and now we have an FDA cleared product!

Rob Lewis

CEO of Radical Imaging

Innolitics’ team epitomized proficiency, professionalism, and precision. Their expertise extends beyond FDA regulations, encompassing intricate facets of DICOM, radiology workflows, and adept software engineering. Venturing into this without their support would have potentially stretched our timeline to 9 months or more. Earning the FDA clearance (K231385), for us, is more than just an accomplishment; it’s a monumental milestone.

Amr Abodraiaa

CEO of Rology

With updated cybersecurity requirements rolled out during our recent FDA submission, we found ourselves looking for an experienced partner to help us navigate this new environment. We reached out to Innolitics, and they were able to quickly assess our device, develop a strategy, and meet with FDA to find a path forward. Their strategic involvement guided us toward an approach that satisfied the FDA and saved us significant upfront and on-going effort. Innolitics’ combination of software and FDA regulatory expertise was invaluable.

Eric Runde

COO at Indica Labs

Top Regulatory Resources

Here are a few of the many articles we published on US FDA regulatory topics:

Medical-Device Software Regulations: Best Practices, FAQs, and Examples

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

ArticleRegulatory

AI/ML from Idea to FDA

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, and Document) and discusses the costs, time, and data requirements involved. It also provides advice on regulatory strategy, data annotation, and algorithm prototyping. If you’re interested in developing a medical device involving AI/ML.

Yujan Shrestha

ArticleAI/ML Regulatory

Get to Market Faster with Software-Savvy Regulatory Experts

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 for interviewing regulatory consultants.

J. David Giese

ArticleSoftware

Medical Device Cybersecurity: Best Practices, FAQs, and Examples

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 looking to implement or improve their own threat modeling processes.

J. David Giese and Bimba Shrestha

ArticleCybersecurity

PCCPs: Best Practices, FAQs, and Examples

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 our experiences with FDA and our thorough research of the FDA databases.

J. David Giese

ArticleAI/ML Regulatory

FAQ

Can you work with our existing regulatory consultants?

Absolutely! We frequently consult with in house teams on topics related to software, cybersecurity, and AI/ML.

Can you help with other jurisdictions outside the US?

Unfortunately, no. Although most of our team members have experience with CE marking, Health Canada, UKCA, and other regulatory submissions—we’ve decided to focus just on the US market so that we can be experts in this jurisdiction.

We have partners we can coordinate with for international regulatory consulting.

Can you help with hardware-only devices?

Unfortunately, no. Although several of our team members have experience hardware-only devices, we’ve decided to specialize in software-enabled medical devices.

We have partners we can introduce you to for hardware-only devices.

Have other questions? Let’s talk!

Software Development