Grace Powers

Recording is available! Town Hall – Clinical Decision Support Software, Final Guidance MARCH 11, 2026 buff.ly/g0xFali

Who Qualifies for the New FDA PreCheck Pilot Program? buff.ly/Och4IlY

Congress Reauthorizes the Rare Pediatric Disease Priority Review Voucher Program and Clarifies Orphan Drug Exclusivity buff.ly/4x5UIuz

CDRH Learn Module – Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot buff.ly/zK1t07V

Quality Management System Regulation (QMSR) buff.ly/U7ibpnV

FDA relaxes oversight of general wellness devices, CDS software buff.ly/ktogRfi

A Busy Day in the (CDRH) Neighborhood: Updates to the CDS and General Wellness Guidance Documents buff.ly/Nge9x0O

US FDA to limit regulation of health and fitness wearables, commissioner says buff.ly/O0Cl6q8

When FDA Can Make You Recall That Mascara buff.ly/cXZueHu

FDA has authorized more than 1,200 artificial intelligence (AI)-based digital devices for marketing. To date, none of these has been indicated to address mental health buff.ly/z4bYyqC

Message from the Biolocity Team! Great news! Biolocity’s call for applications has been extended to January 5, 2026. FAQs buff.ly/fqY93ir

@HeismanTrophy I want to vote for #DiegoPavia

@HeismanTrophy I want to vote for #DiegoPavia

FDA Issues First Draft Guidance in the Countdown to QMSR buff.ly/LiXlBDQ

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 buff.ly/0ODUU4G

GUIDANCE DOCUMENT Electronic Submission Template for Medical Device De Novo Requests - REQUIRED buff.ly/Vp7vLy8

It Lives (for now)!: Congress Revives Pediatric Priority Review Voucher Program with the Give Kids a Chance Act of 2025 buff.ly/eoF2nwj

Do Not Use Unauthorized Infant Devices for Monitoring Vital Signs: FDA Safety Communication buff.ly/DSnZ9Sx