Medmarc Blog (blog.medmarc.com)
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....
CMS Issues Final Policy For Breakthrough Device Coverage
The Centers for Medicare & Medicaid Services has delivered its final policy for the Transitional Coverage for Emerging Technologies (TCET) program, which incorporates existing coverage mechanisms....
Supreme Court Ruling Ends Courts’ Deference under Chevron
The Supreme Court of the United States has overturned a landmark legal doctrine of judicial deference to federal government agencies during litigation in federal courts. The 6-3 decision addresses...
FDA Final Rule for LDTs Offers Four-Year Phase-In
The FDA’s final rule for laboratory-developed tests (LDTs) imposes a large compliance burden on clinical laboratory operations, a fact which has sparked renewed interest in legislation. However, the...
Congress Reconsiders Expanding Telehealth Services for Diabetes Prevention
The House of Representatives and the Senate have both reintroduced legislation that would expand Medicare telehealth services for patients at risk for developing diabetes. The PREVENT DIABETES Act...