Latest Federal Register Notices
CDRH Radiation Safety Panel Seeks Members
Federal Register notice: FDA requests nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. 01/17/2020
Info Collection Extension for BLA Licensing Provsions
Federal Register notice: FDA submits to OMB an information collection extension for BLA general licensing provisions. 01/16/2020
Oncology Pediatric Study Plans Guide
Federal Register notice: FDA makes available a draft guidance entitled “Pediatric Study Plans for Oncology Drugs: Questions and Answers.” 01/15/2020
510(k) Preemption for Powered Wheeled Stretchers
Federal Register notice: FDA exempts powered wheeled stretchers from premarket notification (510(k)) requirements. 01/13/2020
Draft Guide on PTA/Specialty Catheters
Federal Register notice: FDA makes available a draft guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.” 01/13/2020