The Association for Professionals in Infection Control and Epidemiology (APIC) expresses alarm over the Department of Health and Human Services…
Browsing: Regulatory
The number of U.S. product recalls remained high during 2024 with more than 3,200 events recorded for the second consecutive…
READ THE REPORT The 2024 Annual Report illustrates the many ways CDRH continues to advance safe, effective, and high-quality medical…
Earlier this month, the U.S. Department of Veterans Affairs announced that it is beginning early-stage planning to deploy the Federal…
AdvaMed, the Medtech Association, commended the House of Representatives’ bipartisan Task Force on Artificial Intelligence for urging the Centers for…
Today, the U.S. Food and Drug Administration (FDA) issued final guidance on Marketing Submission Recommendations for a Predetermined Change Control…
Recently, the U.S. Food and Drug Administration (FDA) issued this final guidance:Â 510(k) Third Party Review Program and Third Party Emergency…
By Robert J. Kerwin, IAMERS General Counsel EDITOR’S NOTE: This article is for informational purposes only and cannot be construed as…
On October 25, 2024, the U.S. Copyright Office released the report “Section 1201 Rulemaking: Ninth Triennial Proceeding to Determine Exemptions…
The Librarian of Congress, upon the recommendation of the Register of Copyrights, is publishing a final rule in the Federal Register adopting exemptions to…
