Pathways’ Picks January 8: A Global Post-Holiday Catch-up

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ARTICLE SUMMARY:

In this edition of Pathways’ Picks: a rundown of important items you might have missed from the US, Europe, and around the world, on topics including diagnostics reimbursement, third-party 510(k) review, the EU Medical Device Regulation, new China guides on device development, and regulatory timelines in India.

Welcome to 2020! Important medtech regulatory and policy news continued to flow through the holiday and New Year’s period. We’ll catch you up on the most important happenings globally in this latest edition of Pathways’ Picks

Articles from David Filmore:

Providers & Payors

Harmonization in the Fast Lane? COVID-19 Could Accelerate Medtech Regulatory Convergence

If this global pandemic is not a shot in the arm to medtech regulatory convergence efforts, then what will be? Kim Trautman, the longtime global policy leader at FDA and IMDRF, who spearheaded the Medical Device Single Audit Program, is optimistic. Previous harmonization progress has supported the ongoing COVID-19 response, she tells Market Pathways, and it could serve as a catalyst for future success toward, among other things, a global single review program.

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