The Medical Device User Fee Amendments (MDUFA) provide industry with a once-every-five-years opportunity to hold the US Food and Drug Administration accountable for its performance in helping safe, effective devices reach the domestic market quickly. On the flip side, it allows the agency to get the crucial funds from industry that allow it to invest in performance-enhancing measures. For those reasons, regulators and device makers alike are eager to ensure their priorities are addressed in each agreement.
Lifting The Hood On MDUFA V
The document includes promises from the US FDA related to review timelines, consensus standards, the Total Product Life Cycle pilot, and more.
More from Regulation
• 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.
The Doctor Patient Forum says the US FDA should regulate a scoring platform from Bamboo Health intended to help clinicians calculate risk for opioid abuse as a medical device to ensure patient safety.
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.