This new pathway is a considerable change for the medical device industry.
The agency’s intent is to decrease regulatory burden while promoting patient access to products.
How in touch are you with current MDR guidelines?
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.
FDA prioritizes an A-list and B-list for the guidance documents it plans to publish in FY 2017.
Device manufacturers need to identify, monitor and address cybersecurity vulnerabilities as part of postmarket device management.
FDA releases achievements of its Combination Product Review Program, along with next steps for the near term.
Approved by FDA, the changes include a warning and a patient checklist that explains the risks and benefits of the permanent birth control device.
The document clarifies the MDR regulation and reporting requirements for medical device companies.