Medical Devices
-
-
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 As a result, some Web links (URLs) embedded within guidance documents are no longer valid.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.
About Guidance
| Resources |
-
Additional Information
Blue Book Memos - ODE Guidance Memoranda Recent Medical Device Guidance Documents Most Popular Medical Device Guidance Documents 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)
-
?
-
Spotlight
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Draft Guidance for Industry and Food and Drug Administration Staff Draft Guidance for Industry, Clinical Investigators, Institutional Review Boards, and Food and Drug Administration Staff - FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations (PDF) (PDF - 564KB)
-
-
