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Federal
Register Notices Pertaining to the FDA Modernization Act of 1997
| (2/8/2002) | Medical Devices: Device Tracking |  |
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| (1/26/2000) | Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting | |
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| (1/14/2000) | Medical Devices; Exemption from Premarket Notification and Reserved Devices; Class 1 | |
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| (11/23/98) | Medical Devices; Investigational Device Exemptions; Final Rule | |
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| (11/20/98) | Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices | |
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| (11/3/98) | Medical Devices; Exemptions From Premarket Notification; Class II Devices | |
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| (11/3/98) | Humanitarian use devices; Final Rule | |
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| (10/8/98) | Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review; Final Rule | |
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| (9/29/98) | Establishment Registration and Device Listing for Manufacturers and Distributors of Devices | |
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| (1/12/99) Related Document: Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Confirmation of Effective Date | |
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| (11/27/98) Related Document: Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Correction | |
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| (8/07/98) | Medical Devices; Reports of Corrections and Removals (Direct Final Rule) | |
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| (11/18/98) Related Document: Medical Devices: Reports of Corrections and Removals; Delay of Effective Date | |
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| (3/8/2001) | Medical Devices; Final Guidance for Staff, Industry, and Third Parties Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Availability | |
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| Related Document: Implementation of Third Party Programs Under the FDA Modernization Act of 1997 - February 2001. | |
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| (8/9/2000) | Guidance for Industry and for FDA Reviewers; Guidance on Section 216 of the Food and Drug Administration Modernization Act of 1997; Availability | |
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| (9/1/99) | Medical Devices; Draft Guidance on Evidence Models for the Least Burdensome Means to Market; Availability. | |
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| Related Document: Evidence Models for the Least Burdensome Means to Market. | |
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| (4/27/99) | Draft Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices; Administrative Procedures on Use of the Medical Devices Dispute Resolution Panel ; Availability | |
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| Related Document: Draft Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices; Administrative Procedures on Use of the Medical Devices Dispute Resolution Panel | |
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| (2/12/99) | Modernization Act of 1997: Guidance on Medical Device Tracking; Availability | |
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| Related Document: Guidance on Medical Device Tracking (Issued 2/99) | |
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| (1/26/99) | Guidance on Amended Procedures for Advisory Panel Meetings; Availability | |
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| (11/5/98) | Guidance for Industry on General/Specific Intended Use; Availability | |
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| Related Document: Guidance for Industry on General/Specific Intended Use | |
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| (11/3/98) | Guidance on Criteria and Approaches for Postmarket Surveillance; Availability | |
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| Related Document: Guidance on Criteria and Approaches for Postmarket Surveillance | |
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| (11/3/98) | SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols; Availability | |
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| Related Document: SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols | |
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| (11/2/98) | Guidance for Staff, Industry, and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Availability | |
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| Related Document: Implementation of Third Party Programs Under the FDA Modernization Act of 1997 | |
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| (7/02/98) | Draft Guidance for Staff, Industry and Third Parties: Third Party Programs Under the Sectoral Annex on Medical Devices to the Agreement on Mutual Recognition Between the United States of America and the European Community; Availability | |
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| (5/22/98) | Draft Guidance for Staff, Industry, and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Availability | |
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| (5/22/98) | Guidance for Industry on General/Specific Intended Use; Draft; Availability | |
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| (5/21/98) | Guidance for Industry, Supplements to Approved Applications for Class III Medical Devices: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Availability | |
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| (4/01/98) | Guidance to Industry and CDRH for PMAs and PMA Supplements: Use of Published Literature, Use of Previously Submitted Materials, and Priority Review; Draft; Availability | |
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| (3/31/98) | PMA/510(k) Expedited Review Guidance for Industry and Center for Devices and Radiological Health Staff; Availability | |
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| (3/4/98) | Medical Devices; Device Tracking; New Orders to Manufacturers | |
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| (3/4/98) | FDA Modernization Act of 1997: Guidance on Medical Device Tracking; Availability | |
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| (2/25/98) | FDA Modernization Act of 1997: Guidance for the Recognition and Use of Consensus Standards; Availability | |
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| (2/25/98) | FDA Modernization Act of 1997; Guidance Documents for the Medical Device Industry; Availability | |
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| (2/25/98) | Medical Devices; Postmarket Surveillance; Guidance Documents; Availability | |
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| (2/25/98) | Guidance for Industry on Medical Device Appeals and Complaints: A Guidance on Dispute Resolution; Availability | |
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| (2/6/98) | FDA Modernization Act of 1997: Guidance for the Device Industry on Implementation of Highest Priority Provisions; Availability | |
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| (7/12/99) | FDA Modernization Act of 1997: Modifications to the List of Recognized Standards | |
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| (7/12/99) Related Document: FDA Recognized Consensus Standards Appendix A | |
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| (06/22/99) | Public Availability of Information on Clinical Trials for Investigational Devices Intended to Treat Serious or Life-Threatening Conditions; Meeting | |
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| (06/22/99) | Public Availability of Information on Clinical Trials for Investigational Devices Intended to Treat Serious or Life-Threatening Conditions; Request for Comments | |
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| (10/16/98) | Modifications to the List of Recognized Standards; Availability; Withdrawal of Draft Guidance ``Use of IEC 60601 Standards; Medical Electrical Equipment'' | |
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| Related Document: Implementation of Third Party Programs Under the FDA Modernization Act of 1997 | |
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| (7/24/98) | Public Meetings on Section 406(b) of the FDA Modernization Act of 1997 | |
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| (7/02/98) | Agency Emergency Processing Under OMB Review | |
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| (7/02/98) | Agreement on Mutual Recognition Between the United States of America and the European Community; Third Party Review Program Under the Sectoral Annex on Medical Devices; Conformity Assessment Bodies | |
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| (5/22/98) | Medical Devices; Implementation of Third Party Review Under the Food and Drug Administration Modernization Act of 1997; Emergency Processing Request Under OMB Review | |
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| (5/21/98) | Prompt Review of Supplemental Applications for Approved Devices | |
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| (2/2/98) | Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I | |
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| (1/21/98) | Medical Devices; Exemptions From Premarket Notification; Class II Devices | |
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| (12/18/97) | Changes in Medical Device Tracking and Postmarket Surveillance Authority; Public Meeting | |
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Updated 2/12/02
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