💉FDA Updates on Susceptibility Test Interpretive Criteria Announced
21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web Page; Request for Comments
Summary
The Food and Drug Administration (FDA, the Agency, or we) is announcing the availability of the Agency's annual compilation of notices of updates to the Agency's Susceptibility Test Interpretive Criteria web page. The Agency established the Susceptibility Test Interpretive Criteria web page on December 13, 2017, and since establishment has provided updates to both the format of the web pages and the susceptibility test interpretive criteria identified and recognized by FDA on the web pages. FDA is publishing this notice in accordance with procedures established by the 21st Century Cures Act (Cures Act).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The notice involves updates to the Susceptibility Test Interpretive Criteria, which affects compliance and regulatory requirements for pharmaceutical businesses, particularly in antimicrobial susceptibility testing. Changes to recognized standards can impact product development and market entry for related medical devices.