The comment period for the CDRH fiscal year 2026 (FY 2026) proposed guidance development closed on December 1, 2026 and it was reported recently in RAPS that certain industry participants officially asked both for withdrawal of certain guidances entirely and prioritization of other guidances.
Both Advamed and Abbott requested that the following guidances on FY 2026 guidance development list be withdrawn entirely:
- Evaluation of Thermal Effects of Medical Devices that Produce Tissue Heating and/or Cooling
- Best Practices for Selecting a Predicate Device to Support a Premarket Notification [510(k)] Submission
- Evidentiary Expectations for 510(k) Implant Devices
- Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
All four of these guidances are currently in draft and were found to be controversial after their public draft releases in 2023 and 2024. It was argued by both Advamed and Abbott in FY 2026 priority comment period that these guidances are not based on existing statutes and regulations, introduce uncertainty into the regulatory process, and go against the agency’s longstanding regulatory practices for least burdensome principles, all of which could ultimately hinder innovation, slow device development, and limit or delay the availability of innovative lifesaving technologies. It is worth noting that the withdrawal of any or all of these four guidances could also help support the 2025 Executive Order that called for the elimination of ten regulations, rules, guidances or guidelines for every new one established (i.e, the “10-1” rule).
Advamed, Abbott and Dexcom (Federal Register comment) all shared the view that highest priority FY 2026 “A-List” and “B-List” final and draft guidances consisted of the following:
A-List Final Guidances
- Predetermined Change Control Plans for Medical Devices
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices
A-List Draft Guidances
- Policy for Device Software Functions (title changed from current final guidance of “Policy for Device Software Functions and Mobile Medical Applications”)
B-List Final Guidances
The A-List and B-List final guidances noted above would have major implications for any medical device products planning to go through a marketing submission. The Predetermined Change Control Plan (PCCP) dictates the process to allow for certain changes to a cleared / authorized device that don’t require additional marketing submissions, which is of high consequence to any device company looking to streamline updates or improvements in the future. The use of real-world evidence can seriously impact the practical execution of clinical trials needed to support marketing submissions. And last, but certainly not least, the use of AI in medical devices is of profound importance to the medical device industry and society in general, so clarity in how one can proceed in an AI product marketing submission is vital to advance new technologies and make them available to the public. Advamed accentuated this point by recommending that the AI guidance be reprioritized from the B-List to the A-List for final guidance release.
It is worth noting the A-List draft guidance noted above in the Policy for Device Software Functions is an unusual case, in that the FDA is returning a currently available final guidance to a draft form. The currently available Policy for Device Software Functions and Mobile Medical Applications guidance identifies what device software functions are subject to FDA regulatory oversight as regulated medical devices, but critical to certain industry players, identifies what software or mobile medical application products are not regulated by FDA (or are subject to enforcement discretion and are not regulated at this time). The stakes for software and mobile medical application companies could not be higher, as increased requirements for companies currently operating without FDA oversight could upend their entire business model, but if this guidance expands the definitions and allowances for products that are not regulated by the FDA, an even greater freedom to operate in an unregulated arena could emerge.
Next year will likely see pivotal change for the medical device industry and here is to hoping for greater clarity for in 2026, particularly for those developing cutting edge software and AI technologies.
