View Rule
| Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AF88 | Publication ID: Spring 2008 |
| Title: Electronic Registration and Listing for Devices | |
| Abstract: FDA is proposing to amend the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the requirements in section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) and section 510(p) of the Federal Food, Drug, and Cosmetic Act (the act). Section 510(p) was added to the act by section 207 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), and later amended by section 224 of the Food and Drug Administration Amendments Act of 2007 (FDAAA). This proposed rule would require domestic and foreign device establishments to submit registration and listing data electronically via the Internet using FDA’s Unified Registration and Listing System. This proposed rule would convert registration and listing to a paperless process. However, for those companies that do not have access to the Web, FDA would offer an avenue by which they can register, list, and update information with a paper submission. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Other Significant |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 807 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: PL 107-188, sec 321; 21 USC 360(p) | |
|
Legal Deadline:
None |
||||||
Timetable:
|
| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: Yes | |
| RIN Data Printed in the FR: No | |
|
Agency Contact: Myrna Hanna Regulations Staff Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, 10903 New Hampshire Avenue, WO-66 Room 4436, Silver Spring, MD 20993 Phone:301 796-5739 Fax:301 847-8144 Email: myrna.hanna@fda.hhs.gov |
|
