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.