Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``Technical Considerations for Additive Manufactured Medical Devices; Guidance for Industry and Food and Drug Administration Staff.'' FDA has developed this leapfrog guidance to provide FDA's initial thoughts on technical considerations specific to devices using additive manufacturing, the broad category of manufacturing encompassing 3-dimensional (3D) printing. This guidance outlines technical considerations associated with additive manufacturing processes as well as testing and characterization for final finished devices fabricated using additive manufacturing.
Food and Drug Administration Categorization of Investigational Device Exemption Devices To Assist the Centers for Medicare and Medicaid Services With Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of the guidance entitled ``FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions; Guidance for Sponsors, Clinical Investigators, Industry, Institutional Review Boards, and Food and Drug Administration Staff.'' This guidance modifies the FDA's current policy on categorization of investigational device exemption (IDE) devices, which assists the CMS in determining whether or not an IDE device should be covered (reimbursed) by CMS. On December 2, 2015, FDA's Center for Devices and Radiological Health (CDRH) and CMS's Coverage and Analysis Group (CAG) executed a Memorandum of Understanding (MOU) to streamline and facilitate the efficient categorization of investigational medical devices in order to support CMS's ability to make Medicare coverage (reimbursement) determinations for those devices. This guidance document further explains the framework that FDA intends to follow for such categorization decisions.
Agency Information Collection Activities; Proposed Collection; Public Comments Request; New Data Collection; National Center on Law and Elder Rights (NCLER)
The Administration for Community Living (ACL) is announcing an opportunity for the public to comment on ACL's intention to collect information from legal and aging/disability service professionals. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish a notice in the Federal Register concerning each proposed collection of Information and to allow 60 days for public comment in response on the proposed action. This notice solicits comments on proposed information collection requirements relating to ACL funded training, case consultation, and technical assistance for aging/disability networks assisting older adults in social or economic need facing legal issues.