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- FDA Releases 2025 Medical Device Guidance Documents
Each year, the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) identifies the guidance documents (medical devices and radiation-emitting products) to be included in CDRH’s annual guidance agenda for their upcoming fiscal year (October 1 -September 30).
The agency recently released a list of the 2025 guidance documents that the FDA intends to develop, were issued as drafts, or previously issued as final guidance, with the goal of receiving feedback about whether any should be revised or withdrawn.
Among the priority guidance documents CDRH intends to publish during FY 2025, CAP Advocacy will monitor the following:
Final guidance topics:
- Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions Guidance for Industry and Food and Drug Administration Staff
- Laboratory Developed Tests: Enforcement Discretion Policy Regarding Special Controls
- Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices (revision)
Draft guidance topics:
- Artificial Intelligence-Enabled Device Software Functions:
- Lifecycle Management Considerations and Pre-market Submission Recommendations Enforcement Discretion Policy for Certain Laboratory Developed Tests for Unmet Needs
- Frequently Asked Questions
In addition to advocating on behalf of the specialty, the CAP is a resource and partner as your laboratory prepares for upcoming regulations. See the latest resources, webinars, and advocacy efforts offered by the CAP to help prepare for the five-stage phaseout policy on the CAP’s Laboratory-Developed Test Oversight page.