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| HHS/FDA | RIN: 0910-AF88 | Publication ID: Fall 2007 |
| 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 new 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, which was added by section 207 of the Medical Device User Fee and Modernization Act of 2002 (MDUFMA). 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 the registration and listing process to a paperless process. 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) | |
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Legal Deadline:
None |
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Statement of Need: FDA is proposing to amend the medical device establishment registration and listing requirements under 21 CFR part 807 to reflect the new requirements in section 321 of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (BT Act) and section 207 of MDUFMA. This proposed rule would improve FDA’s device establishment registration and listing system and utilize the latest technology in the collection of this information. |
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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 Federal Food, Drug, and Cosmetic Act. |
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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. |
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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. |
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Risks: None |
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Timetable:
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| 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 | |
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Agency Contact: Myrna Hanna Regulations Staff Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health (HFZ-215), 1350 Piccard Drive, PI50 RM150F, Rockville, MD 20850 Phone:240 276-2347 Fax:240 276-2352 Email: myrna.hanna@fda.hhs.gov |
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