Medmarc Blog (blog.medmarc.com)
FDA Releases Cybersecurity Modernization Plan
The FDA has released an action plan for modernizing the agency’s cybersecurity capabilities, a component of the FDA digital transformation project. This plan uses the Zero Trust paradigm for...
FDA Issues Cybersecurity Action Plan for Agency IT Systems
The FDA has released an action plan to update its approach to internal cybersecurity, the Cybersecurity Modernization Action Plan (CMAP). This plan will improve the agency’s overall standing...
FDA Revisits Validation for Production Computer Systems
The FDA has released a draft guidance for computer software assurance (CSA), which when finalized will represent a significant change in how the agency regulates computer systems used in device...
FDA Post-Approval Studies Guidance Applies Tighter Timelines
The new FDA final guidance for post-approval studies (PAS) accelerates some of the timelines in the previous version, and introduces some new deadlines to this policy. These changes are the same...
FDA Guidance Addresses Definition of Counterfeit Devices
The FDA has published a draft guidance that explains the agency’s authority to destroy counterfeit devices, an authority the agency did not enjoy until passage of the Safeguarding Therapeutics...