| Federal
Register: Cardiovascular and Neurological Devices; Reclassification of Two
Embolization Devices |
December
30, 2004 |
| Federal
Register: Guidance for Industry and FDA Staff; Class II Special Controls
Guidance Document: Vascular and Neurovascular Embolization Devices; Availability |
December
30, 2004 |
| Federal
Register: Advisory Committees; Tentative Schedule of Meetings for 2005 |
December
20, 2004 |
| Federal
Register: Medical Devices; Availability of Safety and Effectiveness Summaries
for Premarket Approval Applications. |
December
15, 2004 |
| Federal
Register: Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Implantable Rediofrequency
Transponder System for Patient Identification and Health Information; Availability. |
December
10, 2004 |
| Federal
Register: Medical Devices; General Hospital and Personal Use Devices; Classification
of Implantable Rediofrequency Transponder System for Patient Identification
and Health Information. |
December
10, 2004 |
| Federal
Register: Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting. |
December
9, 2004 |
| Federal
Register: Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Application for Participation
in the Medical Device Fellowship Program |
December
6, 2004 |
| Federal
Register: Guidance for Industry and Food and Drug Administration Staff;
Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices
Intended for Professional Use; Availability |
November
30, 2004 |
| Federal
Register: Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Device Tracking |
November
30, 2004 |
| Federal
Register: Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Newborn Screening Test Systems
for Amino Acids, Free Carnitine, and Acylcarnitines Using Tandem Mass Spectrometry;
Availability. |
November
24, 2004 |
| Federal
Register: Medical Devices; Clinical Chemistry and Clinical Toxicology Devices;
Classification of Newborn Screening Test Systems for Amino Acids, Free Carnitine,
and Acylcarnitines Using Tandem Mass Spectrometry |
November
24, 2004 |
| Federal
Register: Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices; Third-Party
Review Under the Food and Drug Administration Modernization Act. |
November
10, 2004 |
| Federal
Register: Medical Devices; Revision of the Identification of the Iontophoresis
Device; Withdrawal. |
November
4 , 2004 |
| Federal
Register: Medical Devices; Reclassification of the Iontophoresis Device. |
November
4 , 2004 |
| Federal
Register: Neurological Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
October
29, 2004 |
| Federal
Register: Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Third-Party Review Under the Food and
Drug Administration Modernization Act, Third-Party Premarket Submission
Review, and Quality System Inspections Under the United States/European
Community Mutual Recognition Agreement |
October
14, 2004 |
| Federal
Register: Stimulating Innovation in Medical Technologies, Public Meeting. |
October
14, 2004 |
| Federal
Register: Memorandum of Understanding Between the State of Iowa, Department
of Public Health, Bureau of Radiological Health and the Food and Drug Administration,
Center for Devices and Radiological Health. |
October
5, 2004 |
| Federal
Register: Guidance for Industry, Food and Drug Administration Staff, and
Third Parties; Implementation of the Inspection by Accredited Persons Program
Under the Medical Device User Fee and Modernization Act of 2002; Accreditation
Criteria; Availability |
October
4, 2004 |
| Federal
Register: Food and Drug Administration Modernization Act of 1997; Modifications
to the List of Recognized Standards, Recognition List Number: 011. |
October
4, 2004 |
| Federal
Register: Orthopedic Devices; Effective Date of Requirement for Premarket
Approval for Hip Joint Metal/Polymer or Ceramic/Polymer Semiconstrained
Resurfacing Cemented Prosthesis. |
October
4, 2004 |
| Federal
Register: Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Adverse Event Pilot Program for Medical
Devices. |
September
29, 2004 |
| Related
Documents: Supporting Statement |
September
29, 2004 |
| Federal
Register: Second Annual Stakeholder Meeting on the Implementation of the
Medical Device User Fee and Modernization Act of 2002 Provisions; Public
Meeting - November 18, 2004 |
September
28, 2004 |
| Federal
Register: Guidance for Industry and Food and Drug Administration Staff:
Class II Special Controls Guidance Document: Serological Assays for the
Detection of Beta-Glucan; Availability. |
September
23, 2004 |
| Federal
Register: Medical Devices; Immunology and Microbiology Devices; Classification
of the Beta-Glucan Serological Assay |
September
23, 2004 |
| Federal
Register: Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Application for Participation in the
Medical Device Fellowship Program |
September
20, 2004 |
| Federal
Register: Agency Information Collection Activities; Proposed Collection;
Comment Request; Application for Participation in the Medical Device Fellowship
Program (notice). |
September
20, 2004 |
| Federal
Register: Draft Guidance for Industry and Food and Drug Administration Staff;
Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability |
August
30, 2004 |
| Federal
Register: Medical Devices; Labeling for Menstrual Tampons; Ranges of Absorbency,
Change From "Junior" to "Light". |
August
25, 2004 |
| Federal
Register: Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting. |
August
24, 2004 |
| Federal
Register: Draft Guidances for Industry and Food and Drug Administration
Staff; Class II Special Controls Guidance Document: Dental Noble Metal Alloys
and Class II Special Controls Guidance Document: Dental Base Metal Alloys;
Availability |
August
23, 2004 |
| Federal
Register: Dental Devices; Dental Noble Metal Alloys and Dental Base Metal
Alloys; Designation of Special Controls |
August
23, 2004 |
| Federal
Register: Global Harmonization Task Force, Study Groups 1 and 2; New Proposed
Documents; Availability |
August
23, 2004 |
Related
Documents:
Study Group 1
Study Group 2 |
August
23, 2004 |
| Federal
Register: Joint Meeting of the Ear, Nose, and Throat Devices Panel and the
Dental Products Panel of the Medical Devices Advisory Committee; Notice
of Meeting |
August
18, 2004 |
| Federal
Register: Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Devices; Third-Party Review Under the Food and
Drug Administration Modernization Act |
August
10, 2004 |
| Federal
Register: General and Plastic Surgery Devices; Classification of Silicone
Sheeting |
August
9, 2004 |
| Federal
Register: Establishment of Medical Device User Fee Rates for Fiscal Year
2005 |
August
2, 2004 |
| Federal
Register: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting |
August
2, 2004 |
| Federal
Register: Medical Devices: A Pilot Program to Evaluate a Proposed Globally
Harmonized Alternative for Premarket Procedures; Final Guidance for Industry
and FDA Staff; Availability |
July
23, 2004 |
| Federal
Register: Civil Money Penalties Hearings; Maximum Penalty Amounts and Compliance
With the Federal Civil Penalties Inflation Adjustment Act |
July
20, 2004 |
| Federal
Register: Annual Guidance Agenda |
July
09, 2004 |
| Federal
Register: Agency Emergency Processing Under Office of Management and Budget
Review; Application for Participation in the Medical Device Fellowship Program |
July
09, 2004 |
| Federal
Register: Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket Approval of
Medical Devices |
July
09, 2004 |
| Federal
Register: Request for Nominations for Nonvoting Members Representing Industry
Interests on Public Advisory Panels or Committees. |
July
05, 2004 |
| Federal
Register: Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting |
July
01, 2004 |
| Federal
Register: Devices; Tricalcium Phosphate Granules and Other Bone Grafting
Material for Dental Bone Repair. |
June
30, 2004 |
| Federal
Register: Guidance for Industry and FDA Staff; Draft Class II Special Controls
Guidance Document: Dental Bone Grafting Material; Availability. |
June
30, 2004 |
| Federal
Register: Medical Devices; Availability of Safety and Effectiveness Summaries
for Premarket Approval Applications |
June
25, 2004 |
| Federal
Register: Medical Devices; Effective Date of Requirement for Premarket Approval
for Three Class III Preamendments Devices |
June
24, 2004 |
| Federal
Register: Possible Barriers to the Availability of Medical Devices Intended
to Treat or Diagnose Diseases and Conditions that Affect Children; Request
for Comments |
June
21, 2004 |
| Federal
Register: Dental Products Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
June
18, 2004 |
| Federal
Register: Food and Drug Administration Modernization Act of 1997: Modifications
to the List of Recognized Standards, Recognition List Number: 010 |
June
18, 2004 |
| Federal
Register: Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Adverse Event Pilot Program
for Medical Devices |
June
14, 2004 |
| Federal
Register: Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Medical Devices; Current
Good Manufacturing Practice Quality System Regulation |
June
14, 2004 |
| Federal
Register: Agency Information Collection Activities; Announcement of OMB
Approval; Premarket Notification Submissions |
June
14, 2004 |
| Federal
Register: Draft Guidance for Industry, Food and Drug Administration Staff,
and Food and Drug Administration-Accredited Third-Parties: Requests for
Inspection by an Accredited Person Under the Inspections by Accredited Persons
Program Authorized by the Medical Device User Fee and Modernization Act
of 2002; Availability. |
June
3, 2004 |
| Federal
Register: Guidance for Industry and Food and Drug Administration Staff;
Medical Device User Fee and Modernization Act of 2002, Validation Data in
Premarket Notification Submissions for Reprocessed Single-Use Medical Devices;
Availability |
June
1, 2004 |
| Federal
Register: Guidance for Industry and FDA Staff; User Fees and Refunds for
Premarket Notification Submissions; Availability |
June
1, 2004 |
| Federal
Register: Guidance for Industry and FDA Staff; User Fees and Refunds for
Premarket Notification Submissions; Availability |
May
28, 2004 |
| Federal
Register: Medical Devices Regulated by the Center for Biologics Evaluation
and Research; Availability of Safety and Effectiveness Summaries for Premarket
Approval Applications |
May
27, 2004 |
| Federal
Register: Guidance for Industry and Food and Drug Administration Staff;
Premarket Assessment of Pediatric Medical Devices; Availability. |
May
14, 2004 |
| Federal
Register: Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting. |
May
14, 2004 |
| Federal
Register: Guidance for Industry and Food and Drug Administration Staff;
Class II Special Controls Guidance Document: Immunomagnetic Circulating
Cancer Cell Selection and Enumeration System ; Availability |
May
11, 2004 |
| Federal
Register: Obstetrics and Gynocology Devices Panel of the Medical Devices
Advisory Committee; Notice of Meeting |
May
11, 2004 |
| Federal
Register: Neurological Devices Panel of the Medical Devices Advisory Committee;
Notice of Meeting |
May
11, 2004 |
| Federal
Register: Medical Devices; Immunology and Microbiology Devices; Classification
of the Immunomagnetic Circulating Cancer Cell Selection and |
May
11, 2004 |
| Federal
Register: Medical Devices; Availability of Safety and Effectiveness Summaries
for Premarket Approval Applications |
May
7, 2004 |
| Federal
Register: Medical Devices; Availability of Safety and Effectiveness Summaries
for Premarket Approval Applications |
May
7, 2004 |
| Federal
Register: Medical Reports; Reports of Corrections and Removals; Establishment
Registration and Device Listing: Premarket Approval Supplements; Quality
System Regulation; Importation of Electronic Products; Technical Amendment;
Correction |
May
7, 2004 |
| Federal
Register: Draft Guidance for Industry on Combination Products, Timeliness
of Premarket Reviews, Dispute Resolution; Availability |
May
4, 2004 |
| Federal
Register: Delegation of Authority for the Clinical Laboratory Improvements
Amendments of 1988 (CLIA), Section 353 of the Public Health Service Act
(42 U.S.C. 263a), as amended |
April
27, 2004 |
| Medical
Devices; Semicritical Reprocessed Single-Use Devices; Termination of Exemptions
From Premarket Notification; Requirement for Submission of Validation Data |
April
13, 2004 |
| Agency
Information Collection Activities; Announcement of Office of Management
and Budget Approval; Mammography Facilities, Standards, and Lay Summaries
for Patients |
April
13, 2004 |
| Guidance
for Industry and Food and Drug Administration Staff; Premarket Approval
Applications for Absorbable Powder for Lubricating a Surgeon's Glove; Availability |
April
13, 2004 |
| Medical
Device Reports; Reports of Corrections and Removals; Establishment Registration
and Device Listing: Premarket Approval Supplements; Quality System Regulation;
Importation of Electronic Products; Technical Amendment; Correction (Final
rule; technical amendment; correction). |
April
8, 2004 |
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Premarket Approval of Medical Devices |
April
5, 2004 |
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
March
24, 2004 |
| Gastroenterology-Urology
Devices; Classification for External Penile Rigidity Devices |
March
17, 2004 |
| Draft
Guidance for Industry and Food and Drug Administration Staff; Class II Special
Controls Guidance Document: External Penile Rigidity Devices; Availability |
March
17, 2004 |
| Class
II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection
Systems - Guidance for Industry and FDA Staff |
March
16, 2004 |
| Industry
Exchange Workshop on FDA Clinical Trial Requirements; Public Workshop (April
21-22, 2004) |
March
16, 2004 |
| Class
II Special Controls Guidance Document: Factor V Leiden DNA Mutation Detection
Systems - Guidance for Industry and FDA Staff |
March
15, 2004 |
| Industry
Exchange Workshop on FDA Clinical Trial Requirements; Public Workshop (April
21-22, 2004) |
March
11, 2004 |
| Medical
Device Reports; Reports of Corrections and Removals; Establishment Registration
and Device Listing: Premarket Approval Supplements; Quality System Regulation;
Importation of Electronic Products; Technical Amendment |
March
10, 2004 |
| Agency
Information Collection Activities; Submission for Office of Management and
Budget Review; Comment Request; Premarket Notification Submissions |
March
9, 2004 |
| Agency
Information Collection Activities; Announcement of Office of Management
and Budget Approval; Product Jurisdiction: Assignment of Agency Component
for Review of Premarket Applications |
March
9, 2004 |
| Food
and Drug Administration Modernization Act of 1997: Modifications to the
List of Recognized Standards, Recognition List Number: 009 |
March
8, 2004 |
| Medical
Devices: Cardiovascular Devices: Reclassification of the Arrhythmia Detector
and Alarm; Correction. |
March
8, 2004 |
| National
Mammography Quality Assurance Advisory Committee; Notice of Meeting |
March
4, 2004 |
| Food
and Drug Administration and Food and Drug Administration Medical Device
Industry Coalition Quality Systems Educational Forum: Production and Process
Controls; Public Workshop |
March
4, 2004 |
| Cardiovascular
and Neurological Devices; Reclassification of Two Embolization Devices |
February
25, 2004 |
| Draft
Guidance for Industry and FDA Staff on Class II Special Controls Guidance
Document: Vascular and Neurovascular Embolization Devices; Availability |
February
25, 2004 |
| Circulatory
System Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting |
February
25, 2004 |
| Agency
Information Collection Activities; Proposed Collection; Comment Request;
Medical Devices; Current Good Manufacturing Practice Quality System Regulation |
February
19, 2004 |
| Global
Harmonization Task Force, Study Groups 1, 2, 3, and 4; New Proposed and
Final Documents; Availabilit |
February
18, 2004 |
| Medical
Devices; Revised MedWatch Forms; Availability |
February
17, 2004 |
| Ophthalmic
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
February
17, 2004 |
| Agency
Information Collection Activities; Submission for Office of Management and
Budget Review; Comment Request; Prevention of Medical Gas Mix-ups at Health
Care Facilities |
February
11, 2004 |
| Draft
Guidances for Industry on Improving Information About Medical Products and
Health Conditions; Withdrawal; Availability |
February
10, 2004 |
| Agency
Information Collection Activities; Submission for Office of Management and
Budget Review; Comment Request; Mammography Facilities, Standards, and Lay
Summaries for Patients. |
February
9, 2004 |
| Radiological
Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting |
January
27, 2004 |
| Summary
Information for: Microsulis Corporation Microwave Endometrial Ablation (MEA)
System - P020031 |
January
23, 2004 |
| Saline-Filled
Breast Implant Surgery: Making an Informed Decision (Mentor Corporation)
- Updated January 2004 |
January
14, 2004 |
| Agency
Information Collection Activities; Announcement of Office of Management
and Budget Approval; Medical Device User Fee and Modernization Act Small
Business Qualification Certification (Form FDA 3602). |
January
9, 2004 |
| (PREPUB)
- Draft Guidance for Industry and FDA Staff; Saline, Silicone Gel, and Alternative
Breast Implants, Availability. |
January
8, 2004 |
| Federal
Register Notices Concerning MDUFMA (as of 1/6/04) |
January
7, 2004 |
| Medical
Devices Regulated by the Center for Biologics Evaluation and Research; Availability
of Safety and Effectiveness Summaries for Premarket Approval Applications |
January
6, 2004 |
| Radioimmunoassay
Analysis of Hair to Detect the Presence of Drugs of Abuse; Revocation of
Compliance Policy Guide 7124.06 |
January
5, 2004 |
|
|
