Market Pathways Top 5 May 2022

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The top five Market Pathways articles posted in May to, chosen by readers and editors, include our exclusive Q&A with Mark McClellan, an expert panel discusses new opportunities for medtechs in China, user fee legislation advances on Capitol Hill, plus the IVDR edition of Pathways' Market Scorecard and our monthly FDA Output column tracking approvals, recalls, warning letters, breakthrough devices, and EUAs.

The top five Market Pathways May articles.

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#1: Mark McClellan on Expedited Reimbursement

One of the most widely discussed policy issues is whether there is a need for an expedited reimbursement pathway following the repeal of MCIT. Proponents are promoting TCET in its place. Here, former FDA Commissioner and CMS Administrator Mark McClellan weighs in on this issue, which involves both of his former agencies, along with other challenges facing the industry.

#2: Market Pathways Scorecard: IVDR Edition

Our monthly infographic of stats and facts for the medtech regulatory and policy community. This month: the new EU In Vitro Diagnostics Regulation. Here's a snapshot of timelines, notified body resources, and some key changes from the new requirements.

#3: What’s In and What’s Out? Takeaways from House User Fee Markup

The FDA user bill passed its first congressional test May 11, gaining unanimous subcommittee approval. The markup session was more interesting, though, for discussion on topics not included in the bill. Key takeaways: industry-supported device “remanufacturing” legislation appears less likely to join the user fee bill, while product shortage reporting requirements that worry device firms are still on the table.

#4: Changes in China Present New Opportunities

Experienced medtech China hands discuss the opportunities opening up for Western companies to more easily enter that potentially huge market. These CEOs and advisers share how improvements in the regulatory and IP landscape make finding a reliable Chinese partner easier, while also highlighting how to avoid potential pitfalls along the way.

#5: FDA Output May 2022

Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in May 2022.


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