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 Registration & Listing
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Registration & Listing Federal Register Documents

DATE TITLE    
08/01/08 Medical Device User Fee Rates for Fiscal Year 2009 Text PDF
04/30/08 Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Additional Listing
Information for Medical Device Registration and Listing
Text PDF
02/05/08 Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing.
Text PDF
05/03/05 Medical Device Registration and Listing; Agency Information Collection Activities; Announcement of Office of Management and Budget Approval Text PDF
11/24/04 Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Final Rule

Text

PDF

05/07/04 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

Text

PDF

04/08/04 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

Text

PDF

03/10/04 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; Final Rule

Text

PDF

02/04/04 Human Cells, Tissues, and Cellular and Tissue-Based Products; Interim Final Rule; Correction

Text

PDF

01/27/04 Human Cells, Tissues, and Cellular and Tissue-Based Products; Interim Final Rule; Opportunity for Public Comment

Text

PDF

01/21/03 Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule

Text

PDF

06/18/02 Bar Code Label Requirements for Human Drug Products

Text

PDF

11/27/01 Foreign Establishment Registration and Listing; Final Rule

Text

PDF

10/16/01 Agency Information Collection Activities; Submission for OMB Review; Comment Request

Text

PDF

01/19/01 Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule

Text

PDF

05/14/99 Foreign Establishment Registration and Listing; Proposed Rule

Text

PDF

01/05/99 Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Proposed Rule

Text

PDF

01/05/99 Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Direct Final Rule

Text

PDF

12/04/98 Medical Devices; Reconditioners, Rebuilders of Medical Devices; Revocation of Compliance Policy Guide

Text

PDF

11/27/98 Manufacturers and initial importers of devices; establishment registration and device listing; Final Rule; Correction

Text

PDF

11/27/98 Medical devices: Manufacturers and initial importers of devices; establishment registration and device listing; Proposed Rule

Text

PDF

09/29/98 Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Direct Final Rule

Text

PDF

09/29/98 Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Proposed Rule

Text

PDF

05/14/98 Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products

N/A

PDF

08/28/96 Part 807 - Establishment Registration and Device Listing for Manufacturers and Distributors of Devices

N/A

PDF

07/23/96 Medical Devices; Medical Device Distributor and Manufacturer Reporting; Certification, Registration, Listing, and Premarket Notification Submission; Stay of Effective Date; Revocation of Final Rule

Text

PDF

12/11/95 Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration; Final Rule Opportunity for comment

Text

PDF

09/01/93 21 CFR Parts 804 and 807 Medical Devices; Medical Device Distributor Reporting; Final Rules N/A PDF
04/06/88 Medical Device and Radiological Health Regulations; Editorial Amendments N/A PDF
09/18/86 Medical Device Registration; Recordkeeping Reduction N/A PDF
08/25/78 Medical Device Listing; Final Rule N/A PDF
12/02/77 Medical Devices Device Listing Procedures; Correction N/A PDF
09/30/77 Device Listing Procedures N/A PDF
08/23/77 Establishment Registration and Premarket Notification Procedures Part III N/A PDF
09/03/76 Establishment Registration and Premarket Notification Procedures Part III N/A PDF

Updated August 1, 2008

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