A final guidance issued by the agency on premarket submission content to support device cybersecurity is consistent with last year’s proposal. FDA was not swayed by calls to allow device firms to address cybersecurity risks and mitigation efforts within design history files rather than in premarket submissions.
FDA issued final recommendations to device firms for incorporating cybersecurity testing, data and mitigation efforts into premarket submissions for new devices in advance of a public meeting on the topic planned for later this month.
The agency’s final guidance on the “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices” (FDA-2013-D-0616)...
Preparations for the reauthorization of the Medical Device User Fee Amendments for 2028-2032 are underway, with the US FDA announcing a public meeting for 4 August. After negotiations with industry and other stakeholders, a draft agreement is due to Congress by 15 January 2025.
Robert Foster, HHS deputy general counsel and chief counsel for food, research and drugs, is temporarily heading the Office of Chief Counsel, but a permanent appointee is expected after Michael Stuart's confirmation as HHS general counsel.
The US FDA recently published a draft guidance document for manufacturers of mesh products that are used during several types of hernia repair procedures.
