FDA Issues First Draft Guidance in the Countdown to QMSR

Taking a break at #rapsconvergence to meet Boo!

FDA Request For Public Comment: Measuring and Evaluating Artificial Intelligence-enabled Medical Device Performance in the Real-World

GUIDANCE DOCUMENT Electronic Submission Template for Medical Device De Novo Requests - REQUIRED

It Lives (for now)!: Congress Revives Pediatric Priority Review Voucher Program with the Give Kids a Chance Act of 2025

Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication

FDA Clinical Trials Training Modules

MDUFA VI Reauthorization Public Meeting Hears Many Perspectives on Device User Fees

Stakeholders at odds over FDA’s draft guidance on hernia mesh labeling

FDA Formally Rescinds the LDT Final Rule Following Defeat in Court

Device makers seek flexibility, clarity in Q-sub electronic submission guidance

Medical Device User Fee Rates for Fiscal Year 2026 510(k) premarket notification submission: 4.5% increase. $26,067 and $6,517 for small businesses #regulatory #FDA #510k https://t.co/2dm9tJIQGq

FDA’s Latest Lists for Digital Health Technologies- There are 1,247 AI-enabled devices on the list dating back to 1995.

Recent communications from CDRH indicate that impacts to resources from Reductions-In-Force are causing some Offices in CDRH to delay granting a request for a pre-submission (or Q-Submission) meeting until after written feedback is provided.

Medical Device Software Guidance Navigator

RFA-FD-25-020: Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

FDA plans to roll out AI agency-wide for reviews in June

Federal District Court Vacates FDA’s Laboratory Developed Tests Final Rule

More Uncertainty and Less Advice from FDA Means Companies will Need to Even More Carefully Chart their own Course to Achieve their Goals

Medical Device Notification Warns of Continued Data Integrity Concerns