US FDA Adds To Device 510(k) Exemptions List, Responding To Lost, Now Found, Public Comments
This article was originally published in SRA
Executive Summary
The US Food and Drug Administration is exempting an additional eight medical device products, including a cardiopulmonary bypass adaptor and a urethral dilator, from 510(k) pre-market notification requirements, adding to a list of 120 products it initially exempted1,2.
You may also be interested in...
Biden Administration Is Setting An Example For Safe AI Use In Federal Organizations
A new memorandum by the Director of the Office of Management and Budget initiated a government-wide policy that will appoint AI officers to all agencies to address risks for AI use and serve as an example for greater AI adoption.
US FDA Drugs Center Ready To Break Down Silos On Regulatory Innovation
CDER Director Cavazzoni is promising to increase coordination and collaboration to accelerate broader adoption of innovative clinical trial designs and other approaches to speed drug development. A new "Quantitative Medicine Center of Excellence" illustrates the approach.
New OSP Director To Guide CDER-Wide IT Upgrades; System Enhancements Speed ANDA Assessments
Generic Drug Structured Assessment for Bioequivalence launched in 2023 and has been used in 40 ANDA reviews so far.