FDA Published Proposed Changes To 21 CFR Part 820

FDA published proposed changes to 21 CFR part 820 which seeks to harmonize the regulations with ISO 13485.

Public comment is due before May 24, 2022 related to the proposed changes.

Follow link below.

#gmp #fda #regulations #fda21cfrpart820 #iso13485

https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-good-manufacturing-practices