The FDA’s May 2021 draft guidance for post-approval studies for PMA devices did not present any regulatory novelties, but did propose tighter timelines for filing, reviewing and fulfilling post-approval study (PAS) protocols. However, a review of the agency’s PAS database suggests that both the agency and industry might have a difficult time complying with the proposed new standards for turnaround times for these studies.

The European Commission has posted the first sets of standards for the European Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). The new publications had been long-awaited as more and more manufacturers leverage voluntary consensus standards to comply with requirements across regulatory bodies while promoting international harmonization.

The U.S. FDA’s interest in harmonizing its regulations for medical devices with an international standard is a matter of record, but the agency has found this to be an enormously complicated task. Kim Trautman, executive vice president for medical device services at NSF International, of Ann Arbor, Mich., told BioWorld that the task of rewriting Part 820 to meet ISO 13485 in the middle is no mean feat, but also that it may be delayed again, this time because of the COVID-19 pandemic.