Department of Health and Human Services June 14, 2023 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Content of Premarket Submissions for Device Software Functions.'' This guidance document is intended to provide information regarding the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of safety and effectiveness of device software functions, which are functions that meet the definition of a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This document replaces FDA's ``Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'' issued on May 11, 2005, and updates FDA's thinking related to the documentation FDA recommends sponsors include for the review of device software functions in premarket submissions.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the President's Council on Sports, Fitness & Nutrition (PCSFN) will hold its annual meeting. The meeting will be open to the public.

The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Evaluation of Dietary Protein Intake Requirements, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.