Guidance Documents (Medical Devices and Radiation-Emitting Products)
We have recently redesigned the FDA Web site. As a result, some Web links (URLs) embedded within guidance documents are no longer valid. If you find a link that does not work, please try searching for the document using the document title.
Blue Book Memos - ODE Guidance Memoranda Recent Medical Device Guidance Documents
- Center for Devices and Radiological Health Standard Operating Procedure (SOP) - Level 1, Immediately in Effect Guidance Documents on Premarket Data Issues (PDF - 484KB)
- Standard Operating Procedure for "Notice to Industry" Letters (PDF - 66KB)
Federal Register Notice: Standard Operating Procedure for Notice to Industry Letters CDRH Guidance Development SOP(PDF - 165KB)
- CDRH Customer Service - Please take our survey
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff FDA Decisions for Investigational Device Exemption Clinical Investigations - Guidance for Sponsors, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff(PDF - 631KB)