"CLIA Program; Transfer of Clinical Laboratory Complexity Categorization Responsibility". (30DEC99)
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Prepublication document
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Acupuncture Devices and Accessories; Revocation of Compliance Policy Guide 7124.11. (24DEC99)
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pdf
Prepublication document
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Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (22DEC99)
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Prepublication document |
Premarket Notification; Requirement for Redacted Version of Substantially-Equivalent Premarket Notification.
(21DEC99)
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Prepublication document
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Draft Guidance on the Labeling for Over-the-Counter Sample Collection Systems for Drugs of Abuse Testing;
Availability. (21DEC99)
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Prepublication document
The Draft Guidance
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Medical Devices; Draft Guidance for Resorbable Adhesion Barrier Devices for Use in Abdominal and/or Pelvic Surgery;
Availability. (16DEC99)
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Prepublication document
The Draft Guidance
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Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (14DEC99)
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pdf
Prepublication document
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Hematology and Pathology Devices Panel of the Medical Devices Advisory Committee; Notice of Advisory Committee.
(13DEC99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Reclassification Petitions
for Medical Devices. (10DEC99)
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Prepublication document |
Medical Devices; Availability of Safety and Effectiveness Summaries for PMA. (08DEC99)
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Prepublication document |
Medical Devices; Availability of Safety and Effectiveness Summaries for PMA. (08DEC99)
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Prepublication document |
Draft Compliance Guidance: The Mammography Quality Standards Act Final Regulations Document #3; Availability.
(08DEC99)
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Prepublication document
The Draft Guidance
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Medical Devices; Revocation of Cardiac Pacemaker Registry. (24NOV99)
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Hearing Aid Devices:
Professional and Patient Package Labeling and Conditions for Sale. (22NOV99)
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Prepublication document
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Reuse of Single Use Devices; FDA's Proposed Strategy; Public Meeting. (22NOV99)
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Obstetric and Gynecologic Devices; Reclassification and Classification of Medical Devices Used for In Vitro
Fertilization and Related Assisted Reproduction Procedures; Technical Amendment. (18NOV99)
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Prepublication document
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Medical Devices; Exemptions From Premarket Notification; Class II Devices. (17NOV99)
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Medical Devices; Draft Guidance for Conducting Stability Testing to Support an Expiration Date Labeling Claim for
Medical Gloves; Availability. (16NOV99)
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Prepublication document
Draft Guidance
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Food and Drug Administration/Industry Exchange Workshop on Medical Device Quality Systems Inspection Technique
(QSIT); Public Workshops; Addendum. (15NOV99)
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Prepublication document
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Request for Nominations for Members on Public Advisory Panels or Committees; Medical Devices Dispute Resolution
Panel of the Medical Devices Advisory Committee. (10NOV99)
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Prepublication document
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Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting. (10NOV99)
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Prepublication document
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Medical Devices; Hearing Aids; Technical Data Amendments (Direct Final Rule). (03NOV99)
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Prepublication document
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Medical Devices; Hearing Aids; Technical Data Amendments (Proposed Rule). (03NOV99)
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Prepublication document
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Gastroenterology-Urology Devices; Denial of Request for Change in Classification of Fiber Optic Light Sources.
(03NOV99)
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Prepublication document
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FDA's Proposed Strategy on Reuse of Single Use Devices; Availability. (03NOV99)
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Prepublication document
Proposed Strategy
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Surgeon's and Patient Examination Gloves; Reclassification; Extension of Comment Period. (28OCT99)
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Prepublication document
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Medical Gloves; Draft Guidance Manual; Availability; Extension of Comment
Period. (28OCT99)
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Prepublication document
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Mutual Recognition of Pharmaceutical Good Manufacturing Practices Annex; Public Meeting. (27OCT99)
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Draft Guidance for Industry on Financial Disclosure by Clinical Investigators; Availability. (26OCT99)
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Prepublication document
The Draft Guidance
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Medical Devices; Humanitarian Use
Devices. (25OCT99)
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Prepublication document
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Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (19OCT99)
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Prepublication document |
Jay Marcus; Proposal to Debar; Opportunity for a Hearing. (15OCT99)
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Prepublication document
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Food and Drug Administration/Industry Exchange Workshop on Medical Device Quality Systems Inspection Technique; Public
Workshops; Addendum. (15OCT99)
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Prepublication document |
CDRH 9948. Draft Guidance for Industry on Intraocular Lens; Availability. (14OCT99)
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Prepublication document
The Draft Guidance |
CDRH 9958. Medical Devices; Draft Guidance for the Preparation of a Premarket Notification Application for Processed
Human Dura Mater; Availability. (14OCT99)
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Prepublication document
The Draft Guidance |
Medical Devices; Draft Guidance on Information Disclosure by Manufacturers to Assemblers for Diagnostic X-Ray Systems;
Availability. (08OCT99)
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Prepublication document
The Draft Guidance |
Guidance for Industry on Qualifying for Pediatric Exclusivity; Availability; Revised. (08OCT99)
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Prepublication document
The Guidance |
Medical Devices: Draft Guidance on Premarket Approval Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That
Are Indicated for Diagnosis or Monitoring of HCV Infection or Associated Disease; Availability. (08OCT99)
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Prepublication document
The Guidance |
OC 99268. Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice of
Meeting. (08OCT99)
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Prepublication document |
Agency Information Collection Activities; Announcement of OMB Approval; Dissemination of Information on Unapproved/New Uses
for Marketed Drugs, Biologics, and Devices. (07OCT99)
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Prepublication document
Supporting Statement
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General and Plastic Surgery Devices; Classification of the Nonresorbable Gauze/Sponge for External Use, the Hydrophilic Wound
Dressing, the Occlusive Wound Dressing, and the Hydrogel Wound Dressing. (05OCT99)
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Prepublication document |
Medical Devices; Guidance on Preclinical and Clinical Data and Labeling for Breast Prostheses; Availability. (05OCT99)
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Prepublication document
The Guidance |
Medical Devices: Quality Mammography Standards; Delay of Effective Date. (01OCT99)
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Prepublication document
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General Hospital and Personal Use Devices; Classification of the Subcutaneous, Implanted, Intravascular Infusion Port and
Catheter and the Percutaneous, Implanted, Long-term Intravascular Catheter. (01OCT99)
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Prepublication document |
International Conference on Harmonisation; Choice of Control Group in Clinical Trials. (24SEP99)
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Medical Devices; Gastroenterology and Urology Devices; Classification of the Electrogastrography System. (23SEP99)
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Prepublication document |
Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (23SEP99)
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Prepublication document
The Draft Guidance |
Guidance for Industry on Submission of Abbreviated Reports and Synopses in Support of Marketing Applications; Availability.
(13SEP99)
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Prepublication document
The Guidance |
Food and Drug Administration/Industry Exchange Workshop on Medical Device Quality Systems Inspection Technique. (10SEP99)
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Prepublication document |
Medical Devices; Draft Guidance on Labeling For Laboratory Tests; Availability. (08SEP99)
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Prepublication document
The Draft Guidance
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Agency Information Collection Activities; Announcement of OMB Approval; Survey of Biomedical Equipment Manufacturers for Year
2000 Compliance. (07SEP99)
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Prepublication document
Supporting Statement |
Agency Information Collection Activities; Announcement of OMB Approval; Premarket Approval of Medical Devices. (01SEP99)
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Prepublication document
Supporting Statement |
Medical Devices; Draft Guidance on Evidence Models for the Least Burdensome Means to Market; Availability. (01SEP99)
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Prepublication document
The Draft Guidance |
Neurological Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (01SEP99)
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Prepublication document
Guidance Document for Dura Substitute Devices.
Guidance Document for the Preparation of a Premarket Notification Application for Processed Human Dura Mater
Guidance Document for Neurological Embolization Devices |
Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting. (31AUG99)
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Prepublication document
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Technical Electronic Product Radiation Safety Standards Committee Advisory Committee; Notice of Meeting. (30AUG99)
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Agency Information Collection Activities; Announcement of OMB Approval; Survey of Manufacturers of Computer-Controlled,
Potentially High-Risk Medical Devices Regarding Year 2000 Status. (27AUG99)
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Prepublication document
Supporting Statement
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Agency Information Collection Activities; Submission for OMB Review; Comment Request; Draft Guidance for Industry on Formal
Meetings with Sponsors and Applicants for PDUFA Products. (26AUG99)
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Prepublication document |
Agency Information Collection Activities: Proposed Collection; Comment Request; Hearing Aid Devices: Professional and Patient
Package Labeling and Conditions for Sale. (25AUG99)
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txt or pdf |
Medical Devices; Draft Guidance for Industry on the Electro-Optical Sensors for the In Vivo Detection of Cervical Cancer and
its Precursors: Submission Guidance for an IDE/PMA; Availability. (25AUG99)
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Prepublication document
The Draft Guidance |
General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of the Silicone Inflatable Breast
Prosthesis. Correction (GPO correction - NO FDA Pre-pub display). (23AUG99)
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General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of the Silicone Inflatable Breast
Prosthesis. (19AUG99)
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Prepublication document |
Agency Emergency Processing Under OMB Review; Survey of Biomedical Equipment Manufacturers for Year 2000 Compliance. (16AUG99)
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Prepublication document |
Draft Compliance Program Guidance Manual: Inspection of Medical Devices; Availability. (12AUG99)
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Prepublication document
The Draft Guidance
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Agency Information Collection Activities; Announcement of OMB Approval; Regulations for In Vivo Radiopharmaceuticals Used for
Diagnosis and Monitoring. (11AUG99)
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txt or pdf
Prepublication document
Supporting Statement |
Cardiovascular, Orthopedic, and Physical Medicine Diagnostic Devices; Reclassification of the Cardiopulmonary Bypass
Accessory Equipment, Goniometer Device, and the Electrode Cable Devices. (09AUG99)
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Prepublication document |
Medical Devices; Global Harmonization Task Force: Summary Technical File Documents for Premarket Documentation of Conformity
With Requirements for Medical Devices; Recommendations on the Role of Standards in the Assessment of Medical Devices; and a Recommendation on Medical Device Classification; Availability. (09AUG99)
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Guidance For Industry on Consumer-Directed Broadcast Advertisements; Availability. (09AUG99)
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Prepublication document
The Draft Guidance with Questions & Answers |
Medical Devices; Draft Guidance on the Likelihood of Facilities Inspections When Modifying Devices Subject to Premarket
Approval; Availability. (05AUG99)
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Prepublication document
The Draft Guidance |
Global Harmonization Task Force; Draft Document on Proposal for Reporting of Use Errors with Medical Devices; Availability.
(05AUG99)
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Prepublication document
The Proposal Document |
Update of Guidance Documents at the Food and Drug Administration. (04AUG99)
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Prepublication document
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Medical Devices; Draft Guidance for the Accountability Analysis for Clinical Studies for Ophthalmic Devices; Availability.
(04AUG99)
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Prepublication document
The Draft Guidance |
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products
(VICH); Draft Guidance on VICH GL9 Good Clinical Practices; Request for Comments. (03AUG99)
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Prepublication document
The Draft Guidance
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Medical Devices; Draft Guidance on Quality Systems Regulation Information for Various Premarket Submissions; Availability.
(03AUG99)
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Prepublication document
The Draft Guidance |
Medical Devices; Device Use Safety: Incorporating Human Factors in Risk Management; Availability. (03AUG99)
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Prepublication document
The Draft Guidance
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International Workshop on the Standardization of Whole Blood Coagulation Devices. (02AUG99)
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Prepublication document
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Medical Gloves; Draft Guidance Manual; Availability. (30JUL99)
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Prepublication document
The Draft Guidance
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Home Uterine Activity Monitors Guidance; Availability. (30JUL99)
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Prepublication document
The Guidance |
Enforcement Policy: Electronic Records; Electronic Signatures_Compliance Policy Guide; Guidance for FDA Personnel. (30JUL99)
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Prepublication document |
Computer-Controlled Potentially High Risk Medical Devices_List of Device Types. (30JUL99)
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Prepublication document
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Obstetrics and Gynecology Devices; Reclassification of Home Uterine Activity Monitor. (30JUL99)
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Prepublication document
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Surgeon's and Patient Examination Gloves; Reclassification. (30JUL99)
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Prepublication document
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General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee. Notice of Meeting on August 2.
1999. (23JUL99)
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Prepublication document |
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Dissemination of Information on
Unapproved/New Uses for Marketed Drugs, Biologics, and Devices. (23JUL99)
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Prepublication document |
Information Collection Activities: Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices. (Agency
19JUL99)
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Prepublication document |
Draft Guidance for Industry: Clinical Development Programs for Drugs, Devices, and Biological Products Intended for the
Treatment of Osteoarthritis (OA); Availability. (15JUL99)
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Prepublication document
The Draft Guidance
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FDA Modernization Act of 1997: Modifications to the List of Recognized Standards. (12JUL99)
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Prepublication document
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Medical Devices; Performance Standard for Diagnostic X-Ray Systems; Amendment. (02JUL99)
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Prepublication document
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Agency Emergency Processing Under OMB Review; Survey of Manufacturers of Computer-Controlled Potentially High Risk Medical
Devices Regarding Year 2000 Status. (02JUL99)
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txt |