federal_register: 00-1744
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 |
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| 00-1744 | National Voluntary Conformity Assessment System Evaluation (NVCASE) Program | Notice | The National Institute of Standards and Technology (NIST) hereby announces the establishment of a sub-program under the National Voluntary Conformity Assessment System Evaluation (NVCASE) program to recognize bodies that accredit quality system registrars that register organizations that produce medical devices. This sub-program is being established in accordance with NVCASE regulations in response to a request from a Federal Agency, the Food and Drug Administration (FDA). Accreditation bodies recognized by NIST may then accredit quality system registrars to register applicable organizations that demonstrate that they satisfy designated foreign or domestic mandated regulatory requirements. The action taken under this notice addresses both generic and specific NVCASE requirements to allow NIST to support the FDA in fulfilling its obligations as designating authority under the current United States (U.S.)/European Union (EU) Mutual Recognition Agreement (MRA) medical devices sectoral annex. If additional MRAs covering medical devices are negotiated between the United States and another country or region, additional specific requirements may also be included under this NVCASE activity. Sub-program requirements have been developed in accordance with NVCASE regulations and with public consultation. Public input was obtained at an open meeting on April 15, 1999, and from comments received through May 15, 1999. | 2000-01-26 | 2000 | 1 | https://www.federalregister.gov/documents/2000/01/26/00-1744/national-voluntary-conformity-assessment-system-evaluation-nvcase-program | https://www.govinfo.gov/content/pkg/FR-2000-01-26/pdf/00-1744.pdf | Commerce Department; National Institute of Standards and Technology | 54,352 | The National Institute of Standards and Technology (NIST) hereby announces the establishment of a sub-program under the National Voluntary Conformity Assessment System Evaluation (NVCASE) program to recognize bodies that accredit quality system... |