FDA guidance, policy shifts and enforcement that change what a submission needs, written for the team that has to file it.
FDA released the discussion paper Considerations for the Regulation of Generative AI-Enabled Medical Devices on August 18, 2026 under Docket FDA-2026-N-7874, with comments due October 19. It floats a two-axis risk grid, a competency-based assessment modeled on clinician credentialing, and a voluntary master file for foundation models.
FDA published fiscal year 2027 medical device user fee rates on July 30, 2026, effective October 1. The standard 510(k) fee rises to $28,653 and the small business rate to $7,163, while the establishment registration fee climbs to $13,785 with no small business discount.
FDA posted the draft MDUFA VI commitment letter on July 8, 2026, covering fiscal years 2028 through 2032. It steps the average 510(k) total time from 128 days down to 112, adds a 45-day Focused Follow-Up pre-submission, and creates a not grantable letter for De Novo requests.
FDA posted warning letters on June 30, 2026 to BMC Medical and 3B Medical, both dated May 20 and both stemming from a December 2025 inspection. FDA said firmware changes adding new detection algorithms to devices cleared under K153387 required a new 510(k), and that a shipped firmware fix was never reported as a correction.
FDA issued a closeout letter to Whoop on June 17, 2026, ending the July 14, 2025 warning letter over Blood Pressure Insights. The agency said it does not intend to enforce device requirements against the modified product, citing changes Whoop made and its own revised general wellness guidance from January 6, 2026.
FDA issued the final guidance Content of Human Factors Information in Medical Device Marketing Submissions on May 29, 2026, finalizing a December 2022 draft. It assigns each submission to one of three HF categories, and eSTAR added a matching drop-down effective August 1, 2026.
MHRA published the draft Medical Devices (Amendment) Regulations 2026 and opened a stakeholder impact survey on May 11, 2026, closing June 19. The draft creates an international reliance route recognising approvals from Australia, Canada and the United States, and adds a predetermined change control plan pathway for software.
CMS and FDA announced the RAPID coverage pathway on April 23, 2026. CMS would issue a proposed national coverage determination on the day FDA grants marketing authorization, putting Medicare coverage roughly two months out instead of a year or more. About 40 devices qualify today.
The Quality Management System Regulation replaced the Quality System Regulation in 21 CFR Part 820 on February 2, 2026, incorporating ISO 13485:2016 by reference. FDA retired QSIT the same day and began inspecting against compliance program 7382.850, which opens management review, internal audit and supplier audit records to investigators.
On January 6, 2026 FDA issued revised final versions of its Clinical Decision Support Software and General Wellness guidances, skipping the usual comment period. Software giving a single clinically appropriate recommendation can now fall outside device oversight, and wearables estimating blood pressure, oxygen saturation or glucose can be sold as wellness products.
The Commission adopted COM(2025) 1023 on December 16, 2025, a targeted revision of the MDR and IVDR. It would remove maximum certificate validity, move some software and reusable instruments to lower classes, cut notified body fees for micro and small manufacturers, and create designated pathways for orphan and breakthrough devices. The Commission estimates savings above 3 billion euros a year.
FDA published the Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot in the Federal Register on December 8, 2025 under Docket FDA-2025-N-6461. Up to about ten U.S. manufacturers per clinical area can offer digital health devices to CMS ACCESS model participants without premarket authorization, in exchange for real-world data and a plan to seek clearance.
Commission Decision (EU) 2025/2371, published in the Official Journal on November 27, 2025, confirmed that the actor registration, UDI and device registration, notified bodies and certificates, and market surveillance modules of EUDAMED become mandatory on May 28, 2026. Devices already on the market have until November 27, 2026 to complete UDI registration.
The federal shutdown that began October 1, 2025 ended November 12 after 43 days, the longest on record. During the lapse FDA could not accept new device submissions requiring a user fee, while reviews already paid for continued on MDUFA carryover balances.
FDA issued the draft guidance Quality Management System Information for Certain Premarket Submission Reviews on October 27, 2025 under Docket FDA-2025-D-4051. It replaces a 2003 document and rebuilds what PMA and HDE applicants file around the QMSR taking effect February 2, 2026.
From October 1, 2025, FDA accepts De Novo classification requests only as eSTAR submissions sent through the CDRH Portal. The requirement was set in an August 2024 final guidance and follows the October 2023 eSTAR mandate for 510(k)s.
FDA issued the final guidance Computer Software Assurance for Production and Quality System Software on September 24, 2025, three years after the draft. It supersedes Section 6 of the 2002 General Principles of Software Validation and scales assurance work to the risk each software tool carries.
FDA published a final rule on September 19, 2025 removing the laboratory developed test language it added to 21 CFR 809.3 in May 2024. The action implements the March 31, 2025 vacatur by a federal court in Texas, a decision FDA chose not to appeal.
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