FDA Guidance Documents
Definition
Overview
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
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
Format for Traditional and Abbreviated 510(k)s
510(k) Device Modifications: Deciding When to Submit a 510(k) for a change to an Existing Device (Draft Guidance, July 27, 2011)
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Draft Guidance), December 27, 2011 (pdf)
510(k) Device Modifications: Deciding When to Submit a 510(k) for a change to an Existing Device (Draft Guidance, July 27, 2011)
The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Draft Guidance), December 27, 2011 (pdf)
Guidance for Industry
General Information
FDA Guidance Documents: General and Cross-Cutting Topics
Documents the Center for Devices and Radiological Health is Considering for Development (FY11)
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
Emergo Group: US FDA Medical Device Regulations
Documents the Center for Devices and Radiological Health is Considering for Development (FY11)
Interactive Review for Medical Device Submissions: 510(k)s, Original PMAs, PMA Supplements, Original BLAs, and BLA Supplements
Determination of Intended Use for 510(k) Devices; Guidance for CDRH Staff (Update to K98-1)
FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Performance Assessment
Emergo Group: US FDA Medical Device Regulations
Medical Devices and Radiation-Emitting Products
Cross-Center Guidance Documents
OC Guidance
OCD Guidance
OCER Guidance
ODE Guidance Documents, 2010
ODE Guidance Documents, 1998 - 2009
ODE Guidance Documents, 1976 - 1997
OIVD Guidance Documents
OSB Guidance Documents
CBER, General Biologics Guidance
Recent Medical Device Guidance Documents
Most Popular Medical Device Guidance Documents
OC Guidance
OCD Guidance
OCER Guidance
ODE Guidance Documents, 2010
ODE Guidance Documents, 1998 - 2009
ODE Guidance Documents, 1976 - 1997
OIVD Guidance Documents
OSB Guidance Documents
CBER, General Biologics Guidance
Recent Medical Device Guidance Documents
Most Popular Medical Device Guidance Documents