This new pathway is a considerable change for the medical device industry.
The center will start phasing in efficiencies on March 18.
According to the FDA, more than 90% of products sterilized at the facility are medical devices.
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.