Pathways’ Picks September 14: CDRH Resolve, CMS Reassess, EU Picks, and More

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ARTICLE SUMMARY:

In this week’s roundup: Shuren affirms commitment to MDUFA V goals regardless of congressional action, CMS reassesses criteria for coverage with evidence development (CED) studies; in the EU: inconsistent Summary of Safety and Clinical Performance reports, and IVDR guidance updates; actions in Brazil and China; and significant policy activity at US FDA linked to monkeypox, software assurance, combination products, and more.

Top Picks

From FDA and CMS:

“Full steam ahead” on MDUFA V. New medical device performance goals and other MDUFA V commitments will come into effect October 1 whether or not Congress passes FDA user fee reauthorization in time. The device center has “contingency plans” in place, CDRH Director Jeff Shuren assured attendees at the RAPS 2022 Convergence meeting in Phoenix (convened by the Regulatory Affairs Professionals Society). He said carryover funds from the expiring user fee program will support the efforts. For more details, see: Congress or No Congress, “Full Steam Ahead” on MDUFA V, Shuren Says.”

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