Department of Health and Human Services May 7, 2019 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.'' This guidance document provides an overview of the mechanisms available to applicants through which they can request feedback from or a meeting with FDA regarding potential or planned medical device investigational device exemption (IDE) applications, premarket approval applications (PMAs), humanitarian device exemption (HDE) applications, evaluation of automatic class III designations (De Novo requests), premarket notification (510(k)) submissions, Clinical Laboratory Improvement Amendments (CLIA) Waiver by Applications, Dual 510(k) and CLIA Waiver by Application Submissions, Accessory Classification Requests, and certain investigational new drug (IND) applications and biologics license applications (BLAs).
Medicare Program; Changes to the Medicare Claims and Medicare Prescription Drug Coverage Determination Appeals Procedures
This final rule revises the regulations setting forth the appeals process that Medicare beneficiaries, providers, and suppliers must follow in order to appeal adverse determinations regarding claims for benefits under Medicare Part A and Part B or determinations for prescription drug coverage under Part D. These changes help to streamline the appeals process and reduce administrative burden on providers, suppliers, beneficiaries, and appeal adjudicators. These revisions, which include technical corrections, also help to ensure the regulations are clearly arranged and written to give stakeholders a better understanding of the appeals process.
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