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# CDRH Resuming Non-Covid IVD Pre-Submission Reviews
- URL: https://www.fdaweb.com/cdrh-resuming-non-covid-ivd-pre-submission-reviews/
- Published: 2022-05-31T12:00:00.000Z
- Updated: 2026-09-14T17:46:46.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151931

CDRH says that as of 6/1 it plans to again accept all non-Covid in vitro diagnostic (IVD) pre-submissions. In an *FDA Voices* online [post](https://www.fda.gov/news-events/fda-voices/fdas-center-devices-and-radiological-healths-continued-efforts-return-normal-reopening-all-pre?utm%5Fmedium=email&utm%5Fsource=govdelivery), CDRH director **Jeffrey Shuren** and Office of Product Evaluation and Quality director **William Maisel** say that due to the continued elevated workload related to Covid, it is likely that the IVD pre-submissions will initially be reviewed under an extended timeline.

News of the resumption of non-Covid IVD pre-submission acceptance is included in an update on the Center’s Covid-19 submissions and workload. It says CDRH continues to manage a high volume of conventional premarket submissions and requests for emergency use authorization (EUA).

The agency has granted EUAs or traditional marketing authorizations to over 2,300 medical devices for Covid-19, the update says.