Last year the agency surpassed a 40-year record set in 2017, approving 106 novel devices.
The agency will be improving postmarket surveillance, looking at issues that come up once a device is on the market, and promoting innovation.
The program intends to promote quality in medical device design and manufacturing.
Priorities include unique device identification and next-generation sequencing for in vitro diagnostics.
It is surprising how little many people in the medical device industry know about freely-, widely-available resources. Often, many do not know how easy it is to find the regulations and the preambles, or about the existence of Food and Drug Administration mailing lists, phone directories and databases. MedTech Intelligence presents a basic list of non-commercial regulatory reference links, most from FDA itself. Undoubtedly, we have missed some. Send us your suggestions to make this a ‘living, growing’ list.
Wouldn’t you like to stop routine FDA inspections and forego pre-approval inspections?
Manufacturers finally have some clarity on which CGMP requirements apply when producing a combination product.
The center is changing its communication on recalls to minimize confusion among healthcare providers and patients.
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
Highlights include leveraging big data, streamlining clinical trial design, reducing healthcare-associated infections and toughening up on cybersecurity.