| DATE |
TITLE |
| 08/01/08 |
Medical Device User Fee Rates for Fiscal Year 2009 |
| 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 |
| 02/05/08 |
Agency Information Collection Activities; Proposed Collection; Comment Request; Additional Listing Information for Medical Device Registration and Listing.
|
| 05/03/05 |
Medical Device Registration and Listing; Agency Information Collection Activities; Announcement of Office of Management and Budget Approval |
| 11/24/04 |
Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Final Rule |
| 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 |
| 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 |
| 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 |
| 02/04/04 |
Human Cells, Tissues, and Cellular and Tissue-Based Products; Interim Final Rule; Correction |
| 01/27/04 |
Human Cells, Tissues, and Cellular and Tissue-Based Products; Interim Final Rule; Opportunity for Public Comment |
| 01/21/03 |
Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule |
| 06/18/02 |
Bar Code Label Requirements for Human Drug Products |
| 11/27/01 |
Foreign Establishment Registration and Listing; Final Rule |
| 10/16/01 |
Agency Information Collection Activities; Submission for OMB Review; Comment Request |
| 01/19/01 |
Human Cells, Tissues, and Cellular and Tissue-Based Products; Final Rule |
| 05/14/99 |
Foreign Establishment Registration and Listing; Proposed Rule |
| 01/05/99 |
Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Proposed Rule |
| 01/05/99 |
Conforming Regulations Regarding Removal of Section 507 of the Federal Food, Drug, and Cosmetic Act; Direct Final Rule |
| 12/04/98 |
Medical Devices; Reconditioners, Rebuilders of Medical Devices; Revocation of Compliance Policy Guide |
| 11/27/98 |
Manufacturers and initial importers of devices; establishment registration and device listing; Final Rule; Correction |
| 11/27/98 |
Medical devices: Manufacturers and initial importers of devices; establishment registration and device listing; Proposed Rule |
| 09/29/98 |
Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Direct Final Rule |
| 09/29/98 |
Medical Devices; Establishment Registration and Device Listing for Manufacturers and Distributors of Devices; Proposed Rule |
| 05/14/98 |
Establishment Registration and Listing for Manufacturers of Human Cellular and Tissue-Based Products |
| 08/28/96 |
Part 807 - Establishment Registration and Device Listing for Manufacturers and Distributors of Devices |
| 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 |
| 12/11/95 |
Medical Devices; Medical Device User Facility and Manufacturer Reporting, Certification and Registration; Final Rule Opportunity for comment |
| 09/01/93 |
21 CFR Parts 804 and 807 Medical Devices; Medical Device Distributor Reporting; Final Rules |
| 04/06/88 |
Medical Device and Radiological Health Regulations; Editorial Amendments |
| 09/18/86 |
Medical Device Registration; Recordkeeping Reduction |
| 08/25/78 |
Medical Device Listing; Final Rule |
| 12/02/77 |
Medical Devices Device Listing Procedures; Correction |
| 09/30/77 |
Device Listing Procedures |
| 08/23/77 |
Establishment Registration and Premarket Notification Procedures Part III |
| 09/03/76 |
Establishment Registration and Premarket Notification Procedures Part III |
