federal_register: 2012-28015

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2012-28015 Unique Device Identification System Proposed Rule The Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9, 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law; section 614 of FDASIA amends the FD&C Act in ways that require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining. 2012-11-19 2012 11 https://www.federalregister.gov/documents/2012/11/19/2012-28015/unique-device-identification-system https://www.govinfo.gov/content/pkg/FR-2012-11-19/pdf/2012-28015.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is amending its July 10, 2012, proposed rule (77 FR 40736) to establish a unique device identification system as required by recent amendments to the Federal Food, Drug, and Cosmetic Act (the FD&C Act). On July 9,...

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