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U.S. Department of Health and Human Services

Medical Devices

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Registration & Listing Federal Register Documents

DATETITLE
10/10/12Part 807 - Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices
08/01/08Medical Device User Fee Rates for Fiscal Year 2009
04/30/08Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing Information for Medical Device Registration and Listing
02/05/08Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing.
 
05/03/05Medical Device Registration and Listing; Agency Information Collection Activities; Announcement of Office of Management and Budget Approval
11/24/04Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Final Rule
05/07/04Medical Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Correction
04/08/04Medical 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
03/10/04Medical Device Reports; Reports of Corrections and Removals; Establishment Registration and Device Listing: Premarket Approval Supplements; Quality System Regulation; Importation of Electronic Products; Technical Amendment; Final Rule
02/04/04Human Cells, Tissues, and Cellular and Tissue-Based Products; Interim Final Rule; Correction
01/27/04Human Cells, Tissues, and Cellular and Tissue-Based Products; Interim Final Rule; Opportunity for Public Comment
01/21/03Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule
06/18/02Bar Code Label Requirements for Human Drug Products
11/27/01Foreign Establishment Registration and Listing; Final Rule
10/16/01Agency Information Collection Activities; Submission for OMB Review; Comment Request
01/19/01Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule
05/14/99Foreign Establishment Registration and Listing; Proposed Rule
01/05/99Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Proposed Rule
01/05/99Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Direct Final Rule
12/04/98Medical Devices; Reconditioners, Rebuilders of Medical Devices; Revocation of Compliance Policy Guide
11/27/98Manufacturers and initial importers of devices; establishment registration and device listing; Final Rule; Correction
11/27/98Medical devices: Manufacturers and initial importers of devices; establishment registration and device listing; Proposed Rule
09/29/98Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Direct Final Rule
09/29/98Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Proposed Rule
05/14/98Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products
08/28/96Part 807 - Establishment Registration and Device Listing for Manufacturers and Distributors of Devices
07/23/96Medical Devices; Medical Device Distributor and Manufacturer Reporting; Certification, Registration, Listing, and Premarket Notification Submission; Stay of Effective Date; Revocation of Final Rule
12/11/95Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration; Final Rule Opportunity for comment
09/01/9321 CFR Parts 804 and 807 Medical Devices; Medical Device Distributor Reporting; Final Rules
04/06/88Medical Device and Radiological Health Regulations; Editorial Amendments
09/18/86Medical Device Registration; Recordkeeping Reduction
08/25/78Medical Device Listing; Final Rule
12/02/77Medical Devices Device Listing Procedures; Correction
09/30/77Device Listing Procedures
08/23/77Establishment Registration and Premarket Notification Procedures Part III
09/03/76Establishment Registration and Premarket Notification Procedures Part III