The Food and Drug Administration has issued final guidance on federal regulations pertaining to diagnostic X-ray equipment, including “recordkeeping, reporting, manufacturing, importing, and installation of an electronic product.”
X-ray Regulations Detailed In New FDA Guidance
The US FDA has published final guidance to provide clarification for industry and agency staff on federal regulations of diagnostic X-ray equipment.
More from Regulation
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
• By
Cybersecurity, sustainability and regulatory intelligence all need factoring into risk management today as AI and data availability change the goalposts. Eight experts tell Medtech Insight how compliance efforts must adapt.
• By
Pediatric devices and IVDs are to be a priority. And the European Health Data Space regulation is seen as critical in supporting digital technologies and AI in transforming care.
• By
As deadlines approach, the regulatory landscape for medtech batteries is set to change, with an emphasis on sustainability and ethical practices.
More from Policy & Regulation
• By
The IVD industry’s new 10-point plan for healthcare change shows that medtechs will keep calling the German government to account. Tariffs, sector resilience, digital functionality are among the pressing issues industry wants answers to.
• By
The General Services Administration’s updated list of “assets identified for accelerated disposition” does not include any buildings at the agency’s headquarters in White Oak, MD after its original list of “non-core” government properties for disposal had more than half the buildings on campus.
• By
Exer Labs Inc.’s website marketed its AI-based Exer Scan app to “screen and treat Parkinson’s, TB, Cerebral Palsy and more.” But those claims went well beyond what was allowed under the product’s 510(k) clearance, US regulators say.