Medmarc Blog (blog.medmarc.com)
Senate Confirms Marty Makary as FDA Commissioner
The U.S. Senate has confirmed surgeon Marty Makary as the commissioner of the FDA in a March 25 vote of 56-44, installing the oncological surgeon as the agency’s 27th commissioner. The Senate also...
Tariffs Again in Play as Trade Tensions Mount
The global trade picture for medical devices has become more complicated in the first weeks of 2025 as the U.S. has threatened to apply tariffs to a series of trading partners across the globe....
Impact of Federal Funding Freeze on Clinical Trials and Patient Safety
In January 2025, the Trump administration implemented a temporary freeze on federal financial assistance programs, including grants and loans, to review their alignment with the administration’s...
FDA Continues Working to Prevent Device Shortages
The FDA’s Center for Devices and Radiological Health (CDRH) has limited authority to require that device makers provide notice of current and impending device shortages. Nonetheless, CDRH has...
FDA To Seek Expanded Authority for Device Shortage Reporting
The COVID-19 pandemic amplified the FDA’s focus on medical device shortages, but medical device companies are not legally required to report shortages unless the Department of Health and Human...
FDA Stands Its Ground on CDS Guidance
The FDA’s guidance for clinical decision support (CDS) programs has proven unusually controversial, leading to the filing of two petitions that the agency withdraw the guidance. However, the FDA...
FDA Finalizes Guidance for AI Predetermined Change Control Plans
The FDA has published the final version of a guidance for predetermined change control plans (PCCPs) for artificial intelligence (AI) software. The final guidance is limited in terms of scope, but...
FDA Appoints New Director for Center for Devices
The FDA has appointed a new director for the Center for Devices and Radiological Health (CDRH) to replace Jeff Shuren, who has been at the helm of CDRH since 2009. Michelle Tarver has taken over as...
Mammography False Positives Endanger Screening Compliance
A new study published recently in the Annals of Internal Medicine disclosed an association between false positive results on mammography screening exams and a reluctance to return for screening....