ARTICLE SUMMARY:
FDA didn’t publish any new medical device guidance documents for four straight months, but activity has picked up markedly since late May, signaling that the agency’s staff has figured out a path through “deregulatory” directives.
Docs of the Month is a regular column highlighting key findings from Pathways’ Document Depot, a database of global medtech regulatory and policy official documents, including rules, guidances, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
In the first months of the Trump presidency, FDA was less about publishing new documents and more about taking down old ones, primarily to comply with White House orders outlawing diversity and gender identity initiatives and research. Some of the documents were subsequently reposted with edits, but no new guidance or policy development items were forthcoming.
FDA watchers feared that might continue into the foreseeable future considering a January 31 Executive Order from the president, “Unleashing Prosperity Through Deregulation” (EO 14192), that requires agencies to repeal 10 regulations—including guidance and other documents—for every new one promulgated. The order seemed to set a very high bar for issuing anything new.
