The FDA Poses ‘Seven Questions’ to Begin Clarifying Details of the QSR Harmonization with ISO 13485
Last week we reported the breaking news that the FDA, after years of attempts and delays, had finally released the proposed rule to harmonize the current Quality System Regulation (QSR) outlined in 21 CFR 820 with the international standard for medical device quality management system requirements, ISO 13485:2016 to generate a new resulting regulation called […]
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 […]
Is My Product a Medical Device?
Is My Product a Medical Device? I get asked this question quite a lot. It’s important to understand the criteria of what constitutes as a medical device and how medical devices are classified so that the proper regulatory pathway is taken for pre-market clearance or approval, as well as saving yourself the trouble of going […]