FDA Releases Draft Guidance for Electronic Medical Device Submissions
May 29, 2025
May 29, 2025
WASHINGTON, May 29 (TNSFR) -- The Food and Drug Administration, an agency within the U.S. Department of Health and Human Services, has announced the availability of a new draft guidance document.
This guidance, titled "Electronic Submission Template for Medical Device Q-Submissions," aims to streamline the process for submitting certain medical device applications, specifically Pre-Submissions to the Center for Devices and Radiological Health and the Center for Biologics E . . .
This guidance, titled "Electronic Submission Template for Medical Device Q-Submissions," aims to streamline the process for submitting certain medical device applications, specifically Pre-Submissions to the Center for Devices and Radiological Health and the Center for Biologics E . . .