FDA Variance Application from Jennifer Rishel

The Food and Drug Administration (FDA) has made publicly available a variance application submitted by Jennifer Rishel. The application, authored by the Center for Devices and Radiological Health (CDRH), has been posted on regulations.gov. A redacted version of the application is accessible, though the original document is restricted due to personally identifiable information.

This posting serves as a notice of the application's submission. As this is an application for a variance, it does not immediately impose new requirements or obligations on regulated entities. Compliance officers should note the docket number FDA-2026-V-2140-0001 for tracking purposes, but no immediate action is required based solely on this notice.