| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Emergency Medical Device Shortage Program Survey |
December
30, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Medical
Devices: Humanitarian Use Devices |
December
26, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Export
Certificates for FDA Regulated Product |
December
26, 2002
|
| Electronic
Products; Performance Standard for Diagnostic X-Ray Systems and
Their Major Components; Correction |
December
26, 2002
|
| Gastroenterology
and Urology Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
December
24, 2002
|
| Designation
of Special Control for Eight Surgical Suture Devices |
December
19, 2002
|
| Reclassification
and Codification of the Absorbable Polydioxanone Surgical Suture |
December
19, 2002
|
| Federal
Register: Electronic Products; Performance Standard for Diagnostic
X-Ray Systems and Their Major Components |
December
10, 2002
|
| Establishment
of Medical Device User Fee Rates for Fiscal Year 2003 and Interim
Procedures |
November
21, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment
Request; Medical Device Recall Authority |
November
13, 2002
|
| Orthopaedic
and Rehabilitation Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
November
13, 2002
|
| Dental
Devices; Classification for Intraoral Devices for Snoring and/or Obstructive
Sleep Apnea |
November
12, 2002
|
| Medical
Devices; Class II Special Controls Gudiance Document: Intraoral Devices
for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA;
Availability |
November
12, 2002
|
| Draft
Guidance for Industry on Electronic Records; Electronic Signatures, Electronic
Copies of Electronic Records; Availability |
November
12, 2002
|
| Medical
Devices; Ear, Nose, and Throat Devices; Classification of the Transcutaneous
Air Conduction Hearing Aid System |
November
7, 2002
|
| Medical
Devices; Class II Special Controls Guidance Document: Transcutaneous Air
Conduction Hearing Aid System; Guidance for Industry and FDA; Availability |
November
7, 2002
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
November
6, 2002
|
| Diagnostic
X-Ray Field Size; Revocation of Compliance Policy Guide 7133.17; Correction |
November
1, 2002
|
| Determining
Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices; Request
for Comments and Information; Correction
of docket number from ''[Docket No. 00D-0053]'' is corrected to read ''[Docket
No.02N-0456]'' |
October
29, 2002
|
| FDA
Regulation of Combination Products; Public Hearing |
October
26, 2002
|
| Neurological
Devices; Classification of Human Dura Mater |
October
22, 2002
|
| Draft
Guidance for Industry on Class II Special Controls Guidance Document: Human
Dura Mater; Availability |
October
22, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Medical Devices: Humanitarian Use Devices |
October
18, 2002
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
October
17, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Reclassification Petitions for Medical Devices |
October
16, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Guidance for Industry on Formal Dispute Resolution; Appeals Above the Division
Level |
October
16, 2002
|
| Agency
Information Collection Activities: Submission for OMB Review; Comment Request;
FDA Rapid Response Surveys |
October
16, 2002
|
| Diagnostic
X-Ray Field Size; Revocation of Compliance Policy Guide 7133.17 |
October
10, 2002
|
| The
Least Burdensome Provisions of the FDA Modernization Act of 1997; Concept
and Principles; Availability |
October
4, 2002
|
| FDA
Modernization Act of 1997: Modifications to the List of Recognized Standards,
Recognition List Number: 007 |
October
2, 2002
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User
Facility Reporting, and Distributor Reporting |
October
1, 2002
|
| Radiological
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
September
20, 2002
|
| Medical
Devices; Class II Special Controls Guidance Document; Cyclosporine and Tacrolimus
Assays; Availability |
September
16, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Dissemination of Information on Unapproved/New Uses for Marketed Drugs,
Biologics, and Devices |
September
16, 2002
|
| Clinical
Chemistry and Clinical Toxicology Devices; Reclassification of Cyclosporine
and Tacrolimus Assays |
September
16, 2002
|
| Draft
Guidance for Industry: Drugs, Biologics, and Medical Devices Derived From
Bioengineered Plants for Use in Humans and Animals; Availability |
September
12, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Export of FDA Regulated Products--Export Certificates |
September
9, 2002
|
| Medical
Devices; Draft Guidance; Medical Devices Made With Polyvinylchloride Using
the Plasticizer di-(2-Ethylhexyl)phthalate; Availability. |
September
6, 2002
|
| Orthopedic
Devices; Denial of Request for Change in Classification of Hip Joint Metal/Metal
Semi-Constrained, With a Cemented Acetabular Component, Prosthesis and Hip
Joint Metal/Metal Semi-Constrained, With an Uncemented Acetabular Component,
Prosthesis |
September
6, 2002
|
| Draft
Guidance for Industry, Electronic Records; Electronic Signatures, Maintenance
of Electronic Records; Availability |
September
5, 2002
|
| Class
III Medical Devices Without Premarket Clearance; Revocation of Compliance
Policy Guide 7124.30 |
September
5, 2002
|
| Determining
Hospital Procedures for Opened-But-Unused, Single-Use Medical Devices; Request
for Comments and Information |
August
28, 2002
|
| Clinical
Studies of Safety and Effectiveness of Orphan Products; Availability of
Grants; Request for Applications (Catalog of Federal Domestic Assistance
No. 93.103) |
August
27, 2002
|
| Medical
Device Use in the Home Health Care Community; Public Meeting |
August
20, 2002
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
August
20, 2002
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Medical Device Recall Authority |
August
19, 2002
|
| Dental
Devices; Classification of the Dental Sonography Device and the Jaw Tracking
Device |
August
14, 2002
|
| Medical
Devices; Class II Special Controls Guidance Document: Dental Sonography
Device and the Jaw Tracking Devices; Draft Guidance for Industry and FDA
Reviewers; Availability |
August
14, 2002
|
| Dental
Products Panel of the Medical Devices Advisory Committee; Notice of Meeting |
August
1, 2002
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Medical Devices: Humanitarian Use Devices |
July
31, 2002
|
| Ear,
Nose, and Throat Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
July
25, 2002
|
| Dental
Devices: Classification of Encapsulated Amalgam Alloy and Dental Mercury
and Reclassification of Dental Mercury; Issuance of Special Controls for
Amalgam Alloy; Proposed Rule |
July
17, 2002
|
| Medical
Devices: Class II Special Controls Guidance Document: Apnea Monitors; Guidance
for Industry and FDA; Availability |
July
17, 2002
|
| Related
Document: Class II Special Controls Guidance Document: Apnea Monitors; Guidance
for Industry and FDA (PDF file) |
July
17, 2002
|
| Ophthalmic
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
July
8, 2002
|
| Obstetrics
and Gynecology Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
July
8, 2002
|
| Cardiac
Ablation Catheters Generic Arrhythmia Indications for Use; Guidance for
Industry; Availability |
July
1, 2002
|
| Related
Document: Guidance for Cardiac Ablation Catheters Generic Arrhythmia Indications
for Use; Guidance for Industry |
July
1, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Medical Devices; Notification of a Health Claim or Nutrient Content Claim
Based on an Authoritative Statement of a Scientific Body |
June
28, 2002
|
| National
Mammography Quality Assurance Advisory Committee; Notice of Meeting |
June
28, 2002
|
| Assuring
Radiation Protection; Availability of a Cooperative Agreement; Request for
Applications |
June
27, 2002
|
| Bar
Code Label Requirements for Human Drug Products; Notice of Public Meeting;
Correction |
June
26, 2002
|
| Advertisements
for High-Intensity Mercury Vapor Discharge Lamps; Revocation of Compliance
Guide 7133.13; Correction |
June
25, 2002
|
| Advisory
Committees: Filing of Annual Reports |
June
25, 2002
|
| Needle-Bearing
Devices; Request for Comments and Information |
June
25, 2002
|
| Guidance
for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic
Surgery; Availability |
June
19, 2002
|
| Related
Document: Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal
and/or Pelvic Surgery; Guidance for Industry |
June
19, 2002
|
| Protection
of Human Subjects in Clinical Trials; Public Meeting |
June
19, 2002
|
| Request
for Nominations for Voting Members on Public Advisory Panels or Committees |
June
19, 2002
|
| Obstetric
and Gynecology Devices; Effective Date of Requirement for Premarket Approval
for Glans Sheath Devices |
June
14, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Labeling Requirements for Color Additives (other than Hair Dyes) and Petitions |
June
14, 2002
|
| Announcement
of Upcoming Obstetrics and Gynecology Devices Panel Meeting - July 22-23,
2002 |
June
12, 2002
|
| Request
for Nominations for Nonvoting Representatives of Consumer Interests on Public
Advisory Panels or Committees |
June
12, 2002
|
| Now
Available: Transcript from the 5/22/02 Technical Electronic Product Radiation
Safety Standards Committee Meeting |
June
12, 2002
|
| Postmarket
Surveillance |
June
6,
2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Medical Devices; State Petitions for Exemption from Preemption |
May
30, 2002
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Export of FDA Regulated Products—Export Certificates |
May
30, 2002
|
| Medical
Device Public Workshop |
May
28, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Emergency
Medical Device Shortage Program Survey |
May
22, 2002
|
| Related
Document: Supporting Statement |
May
22, 2002
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
May
22, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Requirements
for States as Certification Agencies |
May
16, 2002
|
| Related
Document: Supporting Statement |
May
16, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Medical
Devices; Device Tracking |
May
15, 2002
|
| Related
Document: Supporting Statement - Medical Devices; Device Tracking |
May
15, 2002
|
| Dental
Devices; Reclassification of Root-Form Endosseous Dental Implants and Endosseous
Dental Implant Abutments |
May
14, 2002
|
| Medical
Devices; Draft Guidance for Industry and FDA on Class II Special Controls:
Root-Form Endosseous Dental Implants and Abutments; Availability |
May
14, 2002
|
| Exports;
Notification and Recordkeeping Requirements; Stay of Effective Date |
May
14, 2002
|
| Technical
Electronic Products Radiation Safety Standards Committee; Notice of Meeting |
May
2, 2002
|
| Medical
Devices; Class II Special Controls Guidance Document: Hip Joint Metal/Polymer
Constrained Cemented or Uncemented Prosthesis; Availability |
April
30, 2002
|
| Medical
Devices; Ear, Nose and Throat Devices; Reclassification of the Endolymphatic
Shunt Tube With Valve |
April
29, 2002
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Dissemination of Information on Unapproved/New Uses for Marketed Drugs,
Biologics, and Devices |
April
16, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Medical
Device Labeling Regulations |
April
16, 2002
|
| Related
Document: Supporting Statement |
April
16, 2002
|
| Obstetrics
and Gynecology Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
April
1, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Foreign
Establishment Registration and Listing |
March
26, 2002
|
| Related
Document: Supporting Statement |
March
26, 2002
|
| Draft
Guidance for Industry on Electronic Records; Electronic Signatures, Time
Stamps; Availability |
March
20, 2002
|
| Advisory
Committee; Renewals |
March
12, 2002
|
| Microbiology
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
March
1, 2002
|
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Labeling Requirements for Color Additives (Other Than Hair Dyes) and Petitions |
February
28, 2002
|
| Agency
Information Collection Activities; Announcement of OMB Approval; Exports:
Notification and Recordkeeping Requirements |
February
28, 2002
|
| Determination
of Regulatory Review Period for Purposes of Patent Extension; Menicon Z
Rigid Gas Permeable Contact Lens |
February
25, 2002
|
| Clinical
Chemistry and Clinical Toxicology Devices; Reclassification of Cyclosporine
and Tacrolimus Assays |
February
21, 2002
|
| Medical
Devices; Class II Special Controls Guidance Document: Cyclosporine and Tacrolimus
Assays; Draft Guidance for Industry and FDA; Availability. |
February
21, 2002
|
| Medical
Devices; Reclassification of the Cutaneous Carbon Dioxide (PcCO2)
and the Cutaneous Oxygen (PcO2) Monitor |
February
12, 2002
|
| Medical
Devices; Class II Special Controls Guidance Document: Cutaneous Carbon Dioxide
(PcCO2) and Oxygen (PcO2) Monitors; Draft Guidance
for Industry and FDA; Availability |
February
12, 2002
|
| Medical
Devices; Device Tracking |
February
8, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Financial Disclosure by Clinical Investigators |
February
8, 2002
|
| Proposed
Classification for the Resorbable Calcium Salt Bone Void Filler Device |
February
7, 2002
|
| Draft
Guidance for Industry and FDA on Class II Special Controls Guidance Document:
Resorbable Calcium Salt Bone Void Filler Device
| Availability |
February
7, 2002
|
|
Proposed Classification for Medical Washer and Medical Washer-Disinfector |
February
7, 2002
|
|
Medical Devices; Class II Special Controls Guidance Document: Medical Washers
and Medical Washer-Disinfectors |
Availability |
February
7, 2002
|
| State
Certification of Mammography Facilities |
February
6 , 2002
|
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
February
6 , 2002
|
| Determination
of Regulatory Review Period for Purposes of Patent Extension; T-Scan 2000 |
January
25, 2002
|
| Agency
Information Collection Activities; Submission for OMB Review; Comment Request;
Medical Devices; Third-Party Premarket Submission Review and Quality System
Inspections Under United States/European Community Mutual Recognition Agreement |
January
14, 2002
|
| Medical
Devices; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications. |
January
14, 2002
|
| FDA
Modernization Act of 1997: Modifications to the List of Recognized Standards,
Recognition List Number: 006 |
January
14, 2002
|
| Hematology
and Pathology Devices; Reclassification of the Automated Differential Cell
Counter |
January
14, 2002
|
| Medical
Devices: General Principles of Software Validation; Final Guidance for Industry
and FDA Staff; Availability |
January
11, 2002
|
| Related
Document: General Principles of Software Validation; Final Guidance for
Industry and FDA Staff |
January
11, 2002
|
| Ophthalmic
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
January
4, 2002
|
| Advisory
Committees; Tentative Schedule of Meetings for 2002 |
January
3, 2002
|
|
|
