| The
Mammography Quality Standards Act Final Regulations Modifications and Additions
to Policy Guidance Help System #3; Final Guidance for Industry and FDA |
November
29, 2001
|
| Compliance
Guidance - The Mammography Quality Standards Act Final Regulations: Preparing
For MQSA Inspections; Final Guidance for Industry and FDA |
November
29, 2001
|
| Compliance
Program Guidance Manual: Field Implementation of the Sunlamp and Sunlamp
Product Performance Standard, as amended; Final Guidance for Industry and
FDA |
November
29, 2001
|
| Compliance
Program Guidance Manual: Field Implementation of the Sunlamp and Sunlamp
Product Performance Standard, as amended; Final Guidance for Industry and
FDA |
November
26, 2001
|
| Draft
Guidance for Clinical Trial Sponsors on the Establishment and Operation
of Clinical Trial Data Monitoring Committees (Cross Center Document) |
November
20, 2001
|
| Updated
510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and
FDA |
November
20, 2001
|
| Draft
Guidance for FDA Staff - The Leveraging Handbook, An Agency Resource for
Effective Collaborations |
November
9, 2001
|
| MQSA
Final Regulations: Modifications to the Policy Guidance Help System Due
to the September 11, 2001 Terrorist Attacks; Final Guidance for Industry
and FDA |
October
17, 2001
|
| Class
II Special Controls Guidance Document: Indwelling Blood Gas Analyzers; Final
Guidance for Industry and FDA |
October
10, 2001
|
| Medical
Device Reporting - Remedial Action Exemption; Guidance for Industry and
FDA |
September
28, 2001
|
| Draft
Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures,
Glossary of Terms |
September
24, 2001
|
| Draft
Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures,
Validation |
September
24, 2001
|
| Class
II Special Controls Guidance Document: Hip Joint Metal/Polymer Constrained
Cemented or Uncemented Prosthesis; Draft Guidance for Industry and FDA |
September
4, 2001
|
| Radioallergosorbent
Test (RAST) Methods for Allergen-Specific Immunoglobulin E (IgE) 510(k)s;
Final Guidance for Industry and FDA |
August
27, 2001
|
| Guidance
for Saline, Silicone Gel, and Alternative Breast Implants; Final Guidance
for Industry |
August
13, 2001
|
| Class
II Special Controls Guidance Document: Polymethylmethacrylate(PMMA) Bone
Cement 510(k)s; Final Guidance for Industry |
August
6, 2001
|
| Labeling
Recommendations for Single-Use Devices Reprocessed by Third Parties and
Hospitals; Final Guidance for Industry and FDA |
August
2, 2001
|
| Laser
Products-Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance
for Industry and FDA (Laser Notice 50) |
July
26, 2001
|
| A
Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for
Premarket Procedures; Draft Guidance for Industry and FDA Staff |
July
25, 2001
|
|
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