Docs of the Month: FDA's Policy Pace Accelerates

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FDA policy documents have been few and far between during the first few months of the year due to the presidential transition, but activity clearly picked up in May, according to Pathways' Document Depot. China NMPA and the European Commission were also busy last month as they both implemented new overarching regulations.

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. All documents referenced in this article can be accessed in the database.

FDA rolled out 10 policy documents in May, the most from the agency during a single month since last October. The haul, as tracked by Pathways’ Document Depot, signals a thaw in the regulatory “freeze” put into place at the start of President Biden’s administration. Of note, seven of the 10 documents put out last month from FDA are guidance documents, none of which are focused on COVID-19 emergency policies. These are the first non-COVID medical device guidance documents issued since Biden took office.

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