| Orthopaedic
and Rehabilitation Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
December
26, 2001
|
| Medical
Devices; Guidance on Labeling of Reprocessed Single Use Devices; Request
for Comments and Information |
December
20, 2001
|
| Exports:
Notification and Recordkeeping Requirements |
December
19, 2001
|
| Medical
Devices: Draft Guidance on Cardiac Ablation Catheters Generic Arrhythmia
Indications for Use; Availability |
|
| Foreign
Establishment Registration and Listing |
November
29, 2001
|
| Draft
Guidance for Clinical Trial Sponsors on the Establishment and Operation
of Clinical Trial Data Monitoring Committees; Availability |
November
20, 2001
|
| Medical
Devices; Reclassification of Three Anesthesiology Preamendments Class III
Devices into Class II |
November
15, 2001
|
| Medical
Devices; Class II Special Controls Guidance Document: Indwelling Blood Gas
Analyzers; Final Guidance for Industry and FDA; Availability |
November
15, 2001
|
| Related
Document: Medical Devices; Class II Special Controls Guidance Document:
Indwelling Blood Gas Analyzers; Final Guidance for Industry and FDA |
November
15, 2001
|
| Draft
Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for
Effective Collaborations; Availability. |
November
13, 2001
|
| Draft
Guidance for FDA Staff: The Leveraging Handbook, An Agency Resource for
Effective Collaborations |
November
13, 2001
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Third-Party
Review Under FDAMA |
November
5, 2001
|
| Draft
FDA Guidance on the Establishment and Operation of Clinical Trial Data Monitoring
Committees; Public Meeting |
November
5, 2001
|
| Annual
Comprehensive List of Guidance Documents at the Food and Drug Administration |
October
24, 2001
|
| Ophthalmic
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
October
23, 2001
|
| Request
for Nominations for Voting and Nonvoting Consumer Representative Members
on Public Advisory Committees and Panels |
October
23, 2001
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Premarket
Notification 510(k) Submissions |
October
23, 2001
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Survey
of Single-Use Medical Device Reuse and Reprocessing in Hospitals |
October
22, 2001
|
| Clinical
Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting |
October
17, 2001
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Medical Device Labeling Regulations |
October
16, 2001
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Medical Device Registration and Listing |
October
16, 2001
|
| Science
Board to the Food and Drug Administration Advisory Committee; Notice of
Meeting (10/10/01) |
October
11, 2001
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Medical Devices; Third-Party Premarket Submission Review and Quality System
Inspections Under United States/European Community Mutual Recognition Agreement |
October
5, 2001
|
| Draft
Guidance for Industry; Electronic Records; Electronic Signatures, Glossary
of Terms; Availability; Correction |
October
3, 2001
|
| Microbiology
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. |
September
27, 2001
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Rapid Response Surveys. |
September
27, 2001
|
| Draft
Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures,
Glossary of Terms; Availability |
September
24, 2001
|
| Draft
Guidance for Industry, 21 CFR Part 11; Electronic Records; Electronic Signatures,
Validation; Availability |
September
24, 2001
|
| Preparation
for Global Harmonization Task Force Conference in Barcelona, Spain, Including
a Discussion of Guidance Proposed for Comment and Currently Under Development
and Possibilities for New Topics |
September
13, 2001
|
| Medical
Devices; Exemption From Premarket Notification Requirements; Class I Devices
(Final rule; technical amendment) |
September
10, 2001
|
| Orthopedic
and Rehabilitation Devices: Reclassification of the Hip Joint Metal/Polymer
Constrained Cemented or Uncemented Prosthesis |
September
6, 2001
|
| Related
Documents: Class II Special Controls Guidance Document: Hip Joint Metal/Polymer
Constrained Cemented or Uncemented Prosthesis; Draft Guidance for Industry
and FDA |
September
6, 2001
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Color Additive
Certification Requests and Recordkeeping |
August
31, 2001
|
| Clinical
Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory
Committee |
August
31, 2001
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
August
27, 2001
|
| Clinical
Studies of Safety and Effectiveness of Orphan Products; Availability of
Grants; Requests for Applications |
August
27, 2001
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Third-Party Review Under FDAMA |
August
27, 2001
|
| Medical
Devices Dispute Resolution Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
August
24, 2001
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
FDA Recall Regulations |
August
17, 2001
|
| Ophthalmic
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
August
17, 2001
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Premarket
Approval of Medical Devices |
August
14, 2001
|
| Medical
Devices; Guidance for Saline, Silicone Gel, and Alternative Breast Implants;
Final Guidance for Industry; Availability |
August
13, 2001
|
| Orthopedic
and Rehabilitation Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
July
26, 2001
|
| Laser
Products-Conformance with IEC 60825-1, Am.2 and IEC 60601-2-22; Final Guidance
for Industry and FDA (Laser Notice 50); Availability |
July
26, 2001
|
| Medical
Devices; Exemption from Premarket Notification Requirements; Class I Devices;
Technical Amendment |
July
25, 2001
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Survey of Single-Use Medical Device Reuse and Reprocessing in Hospitals |
July
25, 2001
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Financial Disclosure by Clinical Investigators |
July
25, 2001
|
| Medical
Devices; A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative
for Premarket Procedures; Draft Guidance for Industry and FDA Staff; Availability |
July
25, 2001
|
|
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