ARTICLE SUMMARY:
In this week’s Pathways Picks: the International Medical Device Regulators Forum reports on progress with global implementation of its guidelines; ISO standards update; Brazil device/IVD essential principles regulation takes effect; UK fees; FDA clears the first digital wellness software development kit, and issues a patient preference draft guide; Medicare coverage wait list grows; and dates to remember.
[Editor’s note: Join us for a free webinar September 25 on “Clinical Data Requirements: EU vs. US – Critical Differences & Strategies,” moderated by Market Pathways editor David Filmore. Register here to join live and receive a recording of the session.]
Global Picks
Harmonization, standards, and updates from Brazil and the UK:
Progress on global harmonization. The International Medical Device Regulators Forum (IMDRF) churns out guidance documents intended to be implemented by different countries’ authorities to encourage regulatory harmonization. But some IMDRF documents have been adopted by more countries than others, according to a recent report from the group. Guidances outlining harmonized terms and definitions for software as a medical device (SaMD), personalized medical devices, adverse event reporting, and clinical evidence, as well as a guide on carrying out SaMD clinical evaluation, have been fully implemented by the greatest number of participating authorities (eight of a possible 12 agencies) among IMDRF’s library of documents, according to the “Document Implementation Report.” Meanwhile, documents seeking to establish shared global templates for regulatory submissions and laying out harmonized procedures for third-party assessment bodies have been adopted by the least number of authorities among the 31 IMDRF guidelines tracked in the report. The report measures full, partial, or non-implementation among IMDRF committee members and official observers. Notably, it leaves out Russia—still listed as an IMDRF Management Committee member on IMDRF’s website—from the analysis, and it also doesn’t include recently joined IMDRF “affiliate members” from South America, Africa, and the Middle East.
