Insights on Law, Regulatory
Affairs, & Quality Assurance

August 3, 2025

Flags Raised to Question the Validity of the FDA’s Comments Regarding Transfer of a 510(k) Clearance

M. Jason Brooke calls into question the Agency’s restatement and interpretation of the CFR, surfacing additional questions that industry would like answered.

Public Comments

April 6, 2025

Our Suggestions for Enhancing the FDA’s Draft Recommendations for Lifecycle Management of AI Functions

M. Jason Brooke recommends finishing touches to the new draft guidance, requesting finer points on the Agency’s expectations for performance testing.

Public Comments

December 5, 2023

We Ask the FDA to Reconsider its Proposed Best Practices for Selecting a Predicate Device

The FDA wants 510(k) Sponsors to demonstrate that their valid predicate device is best-in-class. M. Jason Brooke explains why this move may be overly burdensome and beyond the Agency’s authority.

Public Comments

July 2, 2023

Our Comments on FDA’s Draft Guidance for Predetermined Change Control for AI/ML Devices

M. Jason Brooke shares his practical and legal concerns with the new draft guidance affecting AI/ML-enabled device software functions, requesting that the Agency ensures clarity and consistency with U.S. regulations and effective FDA policy.

Public Comments

June 14, 2023

Dear Community: There's a Final FDA Guidance on Premarket Submissions for SaMD and SiMD

The final version is a significant improvement to the 2005 version.

News

June 6, 2023

Dear Community: The FDA is Taking Enforcement Action for Noncompliance

This should be a major warning to Medical Device manufacturers, especially SaMD and Digital Therapeutics developers.

Insights

May 31, 2023

FDA Enforcement Action to Synovo Production, Inc.

The FDA cites failure to obtain a new market authorization and failure to document aspects of the Quality System.

Insights

May 3, 2023

Dozens of FDA COVID-19-Related Guidances Will Soon No Longer Be in Effect. Are You Ready?

The FDA issued an Enforcement Transition Guidance, describing their plan to transition from certain COVID-19 era enforcement policies back to “normal operations.”

FDA News

April 3, 2023

Draft FDA Guidance on the Change Control Plan for AI/ML-Enabled Medical Devices

There's a lot of detail to consider in this guidance.

FDA News

March 30, 2023

FDA Guidance on Cybersecurity in Premarket Submissions

If you haven't integrated cybersecurity into your quality and regulatory activities, it's time.

FDA News