ARTICLE SUMMARY:
In this week’s roundup: Looking for new EU notified bodies and an upcoming FDA user fee reauthorization meeting; China measures; Singapore special access route updates; calls for further MDR delays; FDA COVID-19 transition comments; CDRH shortage planning authorities; and more.
Next Picks
What we’re watching for:
New MDR and IVDR notified body. It has been more than two months since the last notified body was listed to operate under the EU Medical Device Regulation, but the 28th MDR notified body appears imminent. According to a progress report presented this week at a Medical Device Coordination Group (MDCG) meeting, a new body has officially been designated under the MDR by the European Commission. It is just awaiting its appearance in the EU NANDO database. On the IVD Regulation, no new notified body has surfaced since last summer. The presented data suggests an additional, seventh IVDR notified body has received an official MDCG recommendation and is just waiting on designation and database listing.
MDUFA meetings. The House Energy and Commerce Health Subcommittee will hold a hearing on reauthorizing FDA’s device user fee program March 30, followed by an FDA public stakeholder meeting set for April 19 now that the agency has published its draft MDUFA V commitment letter, after more than a year of challenging negotiations with industry. For more details, see “FDA Pre-Submissions Capacity Targeted for Growth in User Fee Deal,” Market Pathways, March 23, 2022.
