FDA Guidance Documents



Device Advice: Device Regulation and Guidance (home page)
Overview of Device Regulation
The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications - Final Guidance
Blue Book Memos - ODE Guidance Memoranda (to clarify guidelines)

Guidance for Industry and FDA Staff

Guidance for Industry

General Information

Medical Devices and Radiation-Emitting Products