federal_register: 2010-6662
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-6662 | Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007 | Proposed Rule | The Food and Drug Administration is proposing to amend its regulations governing medical device establishment registration and device listing. The proposed revisions would modify FDA's current regulations at part 807 (21 CFR part 807) to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), which was enacted on September 27, 2007, amended section 510 of the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In accordance with FDAAA, the agency launched FDA's Unified Registration and Listing System (FURLS), and Internet-based registration and listing system. FDAAA requires electronic submission of device registration and listing information unless FDA grants a waiver request. In addition, this proposal would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). It also would update certain provisions in part 807 to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives. | 2010-03-26 | 2010 | 3 | https://www.federalregister.gov/documents/2010/03/26/2010-6662/implementation-of-device-registration-and-listing-requirements-enacted-in-the-public-health-security | https://www.govinfo.gov/content/pkg/FR-2010-03-26/pdf/2010-6662.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration is proposing to amend its regulations governing medical device establishment registration and device listing. The proposed revisions would modify FDA's current regulations at part 807 (21 CFR part 807) to reflect recent... |