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HHS/FDA

RIN: 0910-AF88

Publication ID: Fall 2010

Title: Electronic Registration and Listing for Devices
Abstract: This rule will convert registration and listing to a paperless process. However, for those companies that do not have access to the Web, FDA will offer an avenue by which they can register, list, and update information with a paper submission. The rule also will amend part 807 to reflect the timeframes for device establishment registration and listing established by sections 222 and 223 of Food and Drug Administration Amendment Act (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: Final 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

Statement of Need: FDA is amending the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the electronic submission requirements in section 510(p) of the Act, which was added by section 207 of MDUFMA and later amended by section 224 of FDAAA. FDA also is amending 21 CFR part 807 to reflect the requirements in section 321 of the BT Act for foreign establishments to furnish additional information as part of their registration. This rule will 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. Because of the new FDAAA statutory requirements and the advances in data collection and transmission technology, FDA believes this rulemaking is the preferable alternative.

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	03/26/2010	75 FR 14510
NPRM Comment Period End	06/24/2010
Final Rule	09/00/2011

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