ARTICLE SUMMARY:
In this month’s spotlight from Pathways’ Document Depot: FDA went on a tear in publishing important policies and proposals last month in advance of a feared government shutdown. The shutdown was averted, but significant new documents on cybersecurity, 510(k)s, lab-developed tests, and many other hot-button issues demand the attention of medtech firms.
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, guidance documents, memos, white papers, and more from national authorities, non-governmental groups, and global organizations.
FDA typically tries to roll out as many pending guidance documents and statutorily required reports as it can before the end of a fiscal year to ensure it meets commitments and makes the most of its annual budget. But the threat last month of congressional funding being shut off for an undetermined amount of time in a government shutdown, combined with the fact that a lot of meaty device regulatory issues just happened to be in the agency’s hopper, led to a particularly productive and important month of policymaking for CDRH.
