FDA: Companies Servicing Products Could Get In Hot Water For Remanufacturing
A new draft guidance from the US FDA clarifies what it considers to be remanufacturing. Companies remanufacturing devices are regulated by the agency and may require new premarket applications.
You may also be interested in...
Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Forty-six documents have been posted on the tracker since its last update.
Software Servicers Can Help Keep Products On Market After Manufacturers Stop Providing Support: US FDA
The agency issued a discussion paper that lays out how third-party servicers could help mitigate cybersecurity threats and keep products on the market.
Experts representing manufacturers, patients, providers and federal agencies are being sought by the US government to advise the Office of National Coordinator for Health Information Technology on issues such as health IT standards and specifications.