Docs of the Month: Leave Your Comment

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ARTICLE SUMMARY:

A look at some important draft documents in Pathways’ Document Depot where industry and other groups have the opportunity to provide input right now to help shape the final policies.

Docs of the Month is a regular column highlighting key findings from Pathway’s Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations. Check out the database to access all items referenced below.

Guidances, regulations, and other documents establishing the rules of the road for medical device market access and compliance are prescriptive by nature. But they don’t typically start out that way. Agencies often circulate draft versions of documents or consultations, giving companies and other stakeholders an opportunity put their stamps on the policymaking as it proceeds.

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