Department of Health and Human Services March 12, 2020 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``510(k) Third Party Review Program.'' This guidance provides a comprehensive look into FDA's current thinking regarding the 510(k) Third Party (3P510k) Review Program authorized under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Under the FDA Reauthorization Act of 2017 (FDARA), FDA was directed to issue guidance on the factors that will be used in determining whether a class I or class II device type, or subset of such device types, is eligible for review by an accredited person. The 3P510k Review Program is intended to allow review of devices by 3P510k Review Organizations in order to provide manufacturers of these devices an alternative review process that allows FDA to best utilize our resources on higher risk devices.

This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project ``Evaluation of Learning Health Systems K12 Training Program.''