Department of Health and Human Services October 12, 2016 – Federal Register Recent Federal Regulation Documents
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Draft Government Wide Strategic Plan for FY 2017-2020
The Workforce Innovation and Opportunity Act (WIOA) (Pub. L. 113-128) requires the Interagency Committee on Disability Research (ICDR) to develop a comprehensive government wide strategic plan. This notice invites the general public and other public agencies to comment on the Draft Government Wide Strategic Plan for FY 2017-2020. The plan can be viewed on the ICDR Web site at https://icdr.acl.gov/content/icdr- seeks-comments-draft-government-wide-strategic-plan.
Medical Devices; Custom Devices; Technical Amendment
The Food and Drug Administration (FDA or Agency) is amending its regulations on the definition of a custom device so as to include new enumerated statutory requirements for custom devices under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) as amended by the Food and Drug Administration Safety and Innovation Act (FDASIA). This new provision, under FDASIA, amends the existing custom device exemption and introduces new concepts and procedures applicable to custom devices. This action is being taken to align the regulations with the FD&C Act.
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