FDA Releases New Draft Guidance for Remote Regulatory Assessments
RAPS Regulatory Focus reported last Friday that the US Food and Drug Administration (FDA) released draft guidance on July 22nd that formalizes its plans for using remote regulatory assessments (RRAs) for FDA-regulated products to supplement onsite inspections as we work our way out of pandemic protocols and codify “new-normal” modes of operation. The 17-page draft […]
After Years of Delays, FDA Finally Issues Proposed Rule to Harmonize QSR to ISO 13485
After four long years and constantly slipping timelines, the FDA is finally making good on efforts to harmonize its Quality System Regulation (QSR), defined in 21 CFR 820, with the international standard for medical device quality management systems, ISO 13485, with a proposed rule issued Tuesday, 2/22/2022, with the resulting regulation being dubbed the Quality […]