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HHS/FDA RIN: 0910-AF88 Publication ID: Fall 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. 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. 
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 107-188, sec 321    21 USC 360(a) to 360(j)    21 USC 360(p)   
Legal Deadline:  None

Statement of Need: 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 the BT Act and section 510(p) of the act, which was added by section 207 of MDUFMA and later amended by section 224 of FDAAA. This proposed rule would improve FDA’s device establishment registration and listing system and utilize the latest technology in the collection of this information.

Summary of the Legal Basis: The statutory basis for our authority includes sections 510(a) through (j), 510(p), 701, 801, and 903 of the act.

Alternatives: The alternatives to this rulemaking include not updating the registration and listing regulations and not requiring the electronic submission of registration and listing information. Because of the new statutory requirements, and the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative to the paper system currently in place.

Anticipated Costs and Benefits: The Agency believes that there may be some one-time costs associated with the rulemaking, which involve resource costs of familiarizing users with the electronic system. Recurring costs related to submission of the information by domestic firms would probably remain the same or decrease because a paper submission and postage is not required. There might be some increase in the financial burden on foreign firms since they will have to supply additional registration information as required by section 321 of the BT Act.

Risks: None

Timetable:
Action Date FR Cite
NPRM  04/00/2009    
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