Latest Federal Register Notices
Info Collection on Dietary Supplement GMPs
Federal Register notice: FDA sends to OMB an information collection revision entitled “Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR Part 111.” 11/25/2020
Info Collection on Special Protocols
Federal Register notice: FDA submits to OMB an information collection revision for “Special Protocol Assessments.” 11/25/2020
FDA Reclassifying Some Hepatitis Tests
Federal Register notice: FDA proposes to reclassify certain hepatitis C virus antibody assay devices from Class 3 to Class 2 (general controls and special controls). 11/24/2020
Regs Amended on 510(k)-Exempt Devices
Federal Register notice: FDA amends certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)). 11/24/2020
CDRH Organization Structures Amended in Regs
Federal Register notice: FDA amends its medical device regulations to reflect changes to CDRH’s organizational structure, including the reorganization of its offices. 11/23/2020