MedTech Dive October 18, 2024
Nick Paul Taylor

The Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs, among other topics.

Dive Brief:

  • The Food and Drug Administration released a list of the medical device guidance documents it plans to work on in its 2025 financial year, with topics like laboratory developed tests, artificial intelligence and cybersecurity filling out the agenda.
  • The list, which the FDA published last week, shows that the Center for Devices and Radiological Health intends to develop final guidance on its enforcement discretion policy regarding special controls for LDTs.
  • Other priorities include the finalization of documents on cybersecurity in premarket submissions and predetermined change control plans (PCCPs) for AI, plus the...

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Topics: FDA, Govt Agencies, Provider
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