Compliance
In September, the US FDA asked the public to weigh in on how AI-enabled medical devices perform in real-world settings. With the comment period now closed, the agency has heard back from dozens of stakeholders on how the agency can use clinical outcomes to better understand these devices.
Brain-computer interfaces advance toward trials and commercialization, Oura pushes for FDA-cleared blood pressure monitoring, and regulators weigh AI’s expanding role in mental health and diagnostics amid rising safety concerns.
The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.
The US FDA is updating its menstrual products guidance for the first time since 2005, adding new recommendations for menstrual cups as well as additional testing guidelines. The document also reflects a new awareness of the potential risks of contaminants within menstrual products.
The US FDA has issued a draft guidance document to help device manufacturers navigate the new Quality Management System Regulation (QMSR) concerning premarket approval applications and humanitarian device exemptions applications. The new regs take effect in February.
FDA advisers gave a cautious nod to the idea of using generative AI in mental healthcare during a Nov. 6 panel meeting, saying evidence-backed tools could help expand access – but warning that safety, oversight, and the irreplaceable human connection remain major unanswered questions.
Stay current on regulatory guidelines from around the world with Medtech Insight’s Guidance Tracker. Over 60 documents have been posted on the tracker since its last update.
At the Medical Device Innovation Consortium summit, Cogmedix's Scott Cook discussed the challenges and benefits of transitioning to the FDA's Voluntary Improvement Program, which promotes honesty and opportunities for improvement, leading to faster market access and cost savings.
The US FDA issued eight warning letters in September and October, with ultrasound, surgical and mobile apps among the affected product types.
US FDA inspections of three Philips manufacturing sites earlier this year resulted in a September warning letter that claimed the company was not in conformity with current good manufacturing practices. Philips says it is addressing the agency’s concerns and working to enhance its quality systems.
Miller, FDA acting deputy associate commissioner for inspections and investigations, said veteran inspectors will retain their specialties and potentially acquire new expertise, while new recruits will begin as generalists and then be encouraged to pick a focus area.
Two recent warning letters from the US FDA provide the companies with 30 business days to respond instead of the usual 15. Though not a regulatory requirement, the 15-day time frame has become the standard.
The “Simple Reform” initiative would reverse a 2017 move to ensure FDA investigators were experts in the commodity they inspected or in clinical research regulations.
Europe’s medtech sector is actively supporting the European Commission’s push to cut red tape in environmental legislation. By offering practical solutions, the industry aims to ease regulatory burdens that have hindered innovation and competitiveness while maintaining patient safety.
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
Dexcom has endured recalls, layoffs and leadership change, but interim CEO Jake Leach said the company remains committed to innovating next-gen devices.
Expect fresh scrutiny on skin substitute payments as the Office of the Inspector General found Medicare reimbursement for the products has continued its rapid increase despite fraud and abuse concerns.
The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.
The newly released Unified Agenda, which outlines actions the executive branch plans to take in the coming months, includes several medtech-related proposals.
Legal experts say a recent warning letter from the US FDA to a maker of dental products could upend a long-standing dental industry view that its operations and products are exempt from agency oversight.