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U.S. Department of Health and Human Services

Medical Devices

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Federal Register Notices Pertaining to the FDA Modernization Act of 1997

 

 Final Rules

(2/8/2002)Medical Devices: Device Tracking
(1/26/2000)Medical Device Reporting: Manufacturer Reporting, Importer Reporting, User Facility Reporting, Distributor Reporting
(1/14/2000)Medical Devices; Exemption from Premarket Notification and Reserved Devices; Class 1
(11/23/98)Medical Devices; Investigational Device Exemptions; Final Rule
(11/20/98)Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
(11/3/98)Medical Devices; Exemptions From Premarket Notification; Class II Devices
(11/3/98)Humanitarian use devices; Final Rule
(10/8/98)Medical Devices; 30-Day Notices and 135-Day PMA Supplement Review; Final Rule
(9/29/98)Establishment Registration and Device Listing for Manufacturers and Distributors of Devices
 (1/12/99) Related Document: Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Confirmation of Effective Date
 (11/27/98) Related Document:Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Correction
(8/07/98)Medical Devices; Reports of Corrections and Removals (Direct Final Rule)
 (11/18/98) Related Document: Medical Devices: Reports of Corrections and Removals; Delay of Effective Date

 Notices of Availability

(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
 Related Document: Implementation of Third Party Programs Under the FDA Modernization Act of 1997 - February 2001.
(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
(9/1/99)Medical Devices; Draft Guidance on Evidence Models for the Least Burdensome Means to Market; Availability.
 Related Document: Evidence Models for the Least Burdensome Means to Market.
(4/27/99)Draft Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices; Administrative Procedures on Use of the Medical Devices Dispute Resolution Panel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 (Updated 6/13/2014)
 Related Document: Draft Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices; Administrative Procedures on Use of the Medical Devices Dispute Resolution Panel
(2/12/99)Modernization Act of 1997: Guidance on Medical Device Tracking; Availability
 Related Document: Guidance on Medical Device Tracking (Issued 2/99)
(1/26/99)Guidance on Amended Procedures for Advisory Panel Meetings; Availability
(11/5/98)Guidance for Industry on General/Specific Intended Use; Availability
 Related Document: Guidance for Industry on General/Specific Intended Use
(11/3/98)Guidance on Criteria and Approaches for Postmarket Surveillance; Availability
 Related Document: Guidance on Criteria and Approaches for Postmarket Surveillance
(11/3/98)SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols; Availability
 Related Document: SMDA to FDAMA: Guidance on FDA's Transition Plan for Existing Postmarket Surveillance Protocols
(11/2/98)Guidance for Staff, Industry, and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Availability
 Related Document: Implementation of Third Party Programs Under the FDA Modernization Act of 1997
(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
(5/22/98)Draft Guidance for Staff, Industry, and Third Parties: Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Availability
(5/22/98)Guidance for Industry on General/Specific Intended Use; Draft; Availability
(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
(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
(3/31/98)PMA/510(k) Expedited Review Guidance for Industry and Center for Devices and Radiological Health Staff; Availability
(3/4/98)Medical Devices; Device Tracking; New Orders to Manufacturers
(3/4/98)FDA Modernization Act of 1997: Guidance on Medical Device Tracking; Availability
(2/25/98)FDA Modernization Act of 1997: Guidance for the Recognition and Use of Consensus Standards; Availability
(2/25/98)FDA Modernization Act of 1997; Guidance Documents for the Medical Device Industry; Availability
(2/25/98)Medical Devices; Postmarket Surveillance; Guidance Documents; Availability
(2/25/98)Guidance for Industry on Medical Device Appeals and Complaints: A Guidance on Dispute Resolution; Availability
(2/6/98)FDA Modernization Act of 1997: Guidance for the Device Industry on Implementation of Highest Priority Provisions; Availability

 Other Notices

(7/12/99)FDA Modernization Act of 1997: Modifications to the List of Recognized Standards
 (7/12/99) Related Document: FDA Recognized Consensus Standards
(06/22/99)Public Availability of Information on Clinical Trials for Investigational Devices Intended to Treat Serious or Life-Threatening Conditions; Meeting
(06/22/99)Public Availability of Information on Clinical Trials for Investigational Devices Intended to Treat Serious or Life-Threatening Conditions; Request for Comments
(10/16/98)Modifications to the List of Recognized Standards; Availability; Withdrawal of Draft Guidance "Use of IEC 60601 Standards; Medical Electrical Equipment"
 Related Document: Implementation of Third Party Programs Under the FDA Modernization Act of 1997
(7/24/98)Public Meetings on Section 406(b) of the FDA Modernization Act of 1997
(7/02/98)Agency Emergency Processing Under OMB Review
(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
(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
(5/21/98)Prompt Review of Supplemental Applications for Approved Devices
(2/2/98)Medical Devices; Exemptions From Premarket Notification and Reserved Devices; Class I
(1/21/98)Medical Devices; Exemptions From Premarket Notification; Class II Devices
(12/18/97)Changes in Medical Device Tracking and Postmarket Surveillance Authority; Public Meeting