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Medmarc Blog (blog.medmarc.com)

FDA’s Posts Final Guidance for Remanufacturing

May 14, 2024

The FDA has issued a final guidance for servicing and remanufacturing services for medical devices, which will end the agency’s enforcement discretion for remanufacturing activities. Manufacturers...

GAO Report Highlights FDA Staff Shortages for BiMo Inspections

April 24, 2024

The U.S. Government Accountability Office stated in a recent report that the FDA’s ability to fill openings in its Bioresearch Monitoring (BiMo) workforce has been impeded by several factors, such...

FDA Proposes New Formats for Informed Consent

March 11, 2024

The FDA has issued a new draft guidance for the disclosure of information in informed consent (IC) documents that will align with an overarching rule by the Department of Health and Human Services...

FDA’s Quality System Final Rule a Significant Revision

March 06, 2024

The FDA has published an updated version of its quality management requirements for medical devices, which is known as the Quality Management System Regulation (QMSR). This rule differs from the...

FDA Provides Greater Possibilities for Real-World Evidence

January 30, 2024

In 2023, the FDA prioritized the use of real-world evidence (RWE) for regulatory decision making for medical products, leading to the development of two guidance’s. In both cases, the FDA was...

Regulatory Partners Release guidelines for PCCPs

January 29, 2024

The FDA and two other national regulatory agencies have collaborated on a set of guiding principles for predetermined change control plans, or PCCPs, which are applicable to machine learning-enabled...

White House Announces Women’s Health Research Program

December 27, 2023

The White House has announced a program titled the Initiative on Women’s Health Research, which among other things will amplify ongoing programs at the FDA designed to improve health outcomes for...

FDA Guidance Promises Closer Scrutiny of Medical Device Cybersecurity

November 29, 2023

The FDA’s most recent final guidance for medical device cybersecurity represents a significant shift in the agency’s perspectives regarding cybersecurity, which is part of a broader emphasis on...

FTC Seeks to Remove Medical Patents from FDA’s Orange Book

November 21, 2023

The Federal Trade Commission has challenged more than 100 medical patents the agency believes are improperly listed in the FDA Orange Book, a compendium of drug products the FDA has deemed safe and...

FDA Releases New Draft Guidance for Unapproved Uses

November 03, 2023

The FDA has released a new draft guidance for communications with health care providers (HCPs) regarding unapproved uses of drugs and devices that are commercially available. This is a reissue of a...