Guidance for Industry and FDA Staff - Medical Glove Guidance Manual
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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) (PDF - 2.3MB)
|
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 Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems
|
ODE/DCD/PVDB
ODE/DCD/ICDB
|
1545
|
04/18/10
|
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
|
|
|
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