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.
An upcoming conference brings together FDA and key industry stakeholders to discuss best practices in health hazard evaluations and global recalls.
The agency has posted new education modules about the unique device identification rule.
The agency is creating a virtual center of excellence to expedite the development of combination products.
The agency calls out specific devices that should include human factors data in premarket submissions, along with recommendations for combination products.