federal_register: 2012-28042

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-28042 Medical Devices; Custom Devices; Request for Comments Notice The Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug Administration (FDA) is in the process of developing an implementation strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is seeking information on appropriate uses of the custom device exemption. 2012-11-19 2012 11 https://www.federalregister.gov/documents/2012/11/19/2012-28042/medical-devices-custom-devices-request-for-comments https://www.govinfo.gov/content/pkg/FR-2012-11-19/pdf/2012-28042.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act). The Food and Drug Administration (FDA) is in the process of developing an...

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