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HHS/FDA

RIN: 0910-AF88

Publication ID: Spring 2009

Title: Electronic Registration and Listing for Devices
Abstract: FDA is proposing to amend the medical device establishment registration and listing regulations at 21 CFR part 807 to reflect the electronic submission requirements in 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 in September 2007 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 FDAs 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. The proposed rule also would amend part 807 to reflect the timeframes for device establishment registration and listing established by sections 222 and 223 of FDAAA, and to reflect the requirement in section 510(i) of the Act, as amended by section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act (BT Act), that foreign establishments provide FDA with additional pieces of information as part of their registration.
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
Legal Authority: PL 110-85 PL 107-188, sec 321 PL 107-250, sec 207 21 USC 360(a) through 360(j) 21 USC 360(p)

Legal Deadline: None

Timetable:

Action	Date	FR Cite
NPRM	08/00/2009

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: No
Included in the Regulatory Plan: Yes
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: No
Agency Contact: Madhusoodana Nambiar Regulatory Counsel Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health, WO 66, Room 5518, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-5837 Fax:301 847-8145 Email: madhusoodana.nambiar@fda.hhs.gov