Most Popular Medical Device Guidance Documents

Title	Organization	Doc #	Date
Guidance for Industry and FDA Staff - Medical Glove Guidance Manual	OCER/DSMICA	1661	01/22/08
The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles; Final Guidance for FDA and Industry	CBER CDRH/ODE	1332	10/04/02
Guideline for the Manufacture of In Vitro Diagnostic Products (PDF only)	OIVD	918	01/10/94
Design Control Guidance For Medical Device Manufacturers	OC/DE3	994	03/11/97
Guidance for Industry and FDA Staff: Non-Clinical Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems	ODE/DCD/PVDB ODE/DCD/ICDB	1545	01/13/05
Guidance for Industry and FDA Staff - Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers	OSEL ODE/DRARD	560	09/09/08
Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests	OSB/DB	1620	03/13/07
Guidance for Industry and FDA Staff - Recognition and Use of Consensus Standards	OSEL	321	09/17/07
Guidance on Medical Device Patient Labeling	OCER/DHC	1128	04/19/01
General Principles of Software Validation; Final Guidance for Industry and FDA Staff	CBER CDRH/OC	938	01/11/02
Medical Device Reporting for Manufacturers	OCER/DSMICA	987	03/01/97
Deciding When to Submit a 510(k) for a Change to an Existing Device (K97-1)	ODE	935	01/10/97
The Least Burdensome Provisions - Activities Related to Implementation