By- Elle Winn (Mittal Consulting)

March 12-13, 2025 Palo Alto

Regulatory Shifts and Industry Insights

The Medical Device Manufacturers Association (MDMA) hosted their annual FDA Forum on March 12-13, 2025 in Palo Alto, California. While FDA attendance was limited due to recent return-to-office (RTO) and budget policies, the event still brought in many industry members allowing for presentations and discussions of a variety of important topics. Take home points from the MDMA Conference are as follows:

FDA Submission Takeaways:

• Narrower predicate interpretation in the 510(k) program – Historically, sponsors have been able to bridge larger gaps between subject and predicate devices in substantial equivalence arguments; however, over the past few years industry has seen the gaps FDA is willing to accept narrow. This means choosing strong, similar predicates and providing robust rationale where differences arise are becoming increasingly important.
• Growing popularity of including video attachments in submissions – Many industry members expressed that, despite early hesitance to attach informational videos to submissions, videos have been well accepted by FDA and are beginning an upward trend in popularity among device sponsors. This offers additional opportunities to explain difficult concepts in both informal and formal submissions to FDA, affording deeper understanding and improved interactivity.
• Improved understanding and interactivity when sending devices to FDA (when appropriate) during review – Similarly to incorporating videos in submissions, sending physical devices to FDA (when appropriate and small enough to transport) can increase clarity on the device’s function and composition, increasing the clarity to reviewers during their review process. Furthermore, many industry members expressed that these devices in the hands of FDA reviewers makes them feel more like stakeholders and improves their review process.

Cybersecurity:

There’s an increased emphasis by FDA on cybersecurity; panelists cited a 700% increase in submission rejection year over year due to cybersecurity issues alone. Devices that require cybersecurity analyses are any device that have network connectivity, ports (USB, SIM cards), RF etc. Furthermore, cybersecurity and regulatory experts alike stress the importance of planning cybersecurity activities over the entire product lifetime.

Biocompatibility:

Biocompatibility continues to be a challenge in regulatory submissions. Recent discoveries of falsified biocompatibility data from laboratories in China and India has raised more scrutiny on biocompatibility sections in submissions. Additionally, for sponsors who utilize biocompatibility data from these regions, it is likely that all performance data in that submission will undergo more rigorous examination.

In addition to data concerns, ISO 10993 is currently undergoing revision, which is raising questions on FDA acceptance of the standard going forward. These revisions are expected to be completed end of year 2025.

Digital Health & AI/ML

Digital health and AI/ML are gaining traction in the medical device industry. Devices incorporated with generative AI are emerging, as well as AI-based devices beginning to find success with the pre-determined change control plan (PCCP) program. AI & ML is ever changing. One way to keep up is to check the list of cleared devices with PCCPs curated here by Brendan O’Leary.

Navigating the Changing FDA Landscape

The whole medical device industry has been experiencing a degree of uncertainty and industry members have been closely monitoring ongoing changes at FDA over the past several weeks. At this point, it has not been long enough to draw many definite conclusions about operations; however, president and CEO of MDMA Mark Leahey made a few main points to consider:

• OHTs (FDA Review branches) are each responding differently to these changes, and we will be able to start seeing trends in the next 3-6 months.
• Sponsors should give some grace to FDA staff and be accommodating over the next 3-6 months as FDA regains its bearings.
• Change in regulatory is inevitable and now more than ever is an important time to work with qualified regulatory consultants on FDA submissions. Overall, in both the short and long term, we should expect to get through the challenges we are seeing now.

FDA Policy Going Forward:

• We’re unlikely to see new FDA draft or finalized guidance documents due to the 10:1 executive order
• We’re unlikely to see the Diversity, Equity and Inclusion (DEI) website return under this administration, though it is expected to still see DEI elements incorporated in testing and FDA reviewers are still asking for these elements to be provided.
• MDUFA VI negotiations may change in the face of these challenges. We should expect fees to increase, but it is uncertain by how much. Further, experts expect that negotiations in MDUFA VI may be focused more on keeping the initiatives we already have under MDUFA V (Total Product Lifecycle Advisory Program (TAP), Real-World Evidence (RWE) & Real-World Data (RWD), and the like) rather than adding additional initiatives. There is also the potential for review timelines to lengthen. None of these changes are certain yet, but this may provide for insight on future negotiations for MDUFA VI.

Conclusion

Despite the limited FDA presence, this year’s MDMA FDA Forum provided valuable insights into the evolving regulatory landscape. From shifting submission trends to heightened scrutiny on cybersecurity and biocompatibility, it’s clear that medical device manufacturers must remain adaptable in an ever-changing environment. The growing role of digital health and AI/ML further underscores the importance of staying ahead of regulatory expectations.

As the FDA continues to navigate internal transitions, industry members should anticipate some uncertainty in the coming months. However, as Mark Leahey emphasized, change is inevitable in regulatory affairs—our role is to minimize disruption and push forward. By staying informed, proactive, and flexible, we can successfully navigate these challenges and continue driving innovation in the medical device space.