In late November the FDA released two draft guidance documents addressing manufacturer applications for Clinical Laboratory Improvement Amendments (CLIA) waivers for the in vitro diagnostic (IVD) devices. These draft guidance documents propose updates to the 2008 CLIA Waiver Guidance to meet the updated requirements approved in the 21st Century Cures Act. These documents are

1. Select Updates for Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices – this draft guidance presents a revision to section 5 of the 2008 CLIA Waiver Guidance with updated instructions on how manufacturers can demonstrate that a device is ‘simple’ per the regulations, and 
2. Recommendations for Dual 510(k) and CLIA Waiver by Application Studies – this draft guidance discusses an approach manufacturers can use to perform a single study that will meet the requirements for a dual submission (510(k) + CLIA Waiver) for their IVD.

The Dual program is optional, and the FDA notes that many sponsors first obtain 510(k) clearance and then submit separate information for the CLIA Waiver. The agency believes the dual approach offers a faster method to bring “simple and accurate IVD devices to CLIA waived settings”.

A webinar is scheduled for January 9, 2019. You can provide comments on the draft guidance here.

Text Copyright © 2018 Katrina Rogers