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 Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter...
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The FDA has released a draft guidance for computer software assurance (CSA), which when finalized will represent a significant change in how the agency regulates computer systems used in device...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...
Three Years Since the Draft Guidance was Released, FDA Issues their Final Guidance Document on Clinical Decision Support Software
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types...
Device User Fees Set to Rise Significantly in Fiscal 2023
The FDA has released the user fee schedule for fiscal year 2023 per the terms of the new user fee agreement, and device manufacturers will see considerably higher fee amounts. One example is that the...
Congress Passes FDA User Fee Legislation
The U.S. Congress has passed legislation that reestablishes the FDA user fee programs for medical devices and pharmaceuticals as part of a continuing resolution for the federal fiscal year 2023...
President Biden Signs Executive Order to Launch a National Biotechnology and Biomanufacturing Initiative
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes...
FDA Electromagnetic Compatibility Guidance Covers Investigational Devices
The FDA has released a final guidance for electromagnetic compatibility (EMC) for medical devices, a policy that applies to PMA, 510(k), and de novo devices. However, the scope of the guidance also...