On March 11, 2014, the FDA’s Center for Devices and Radiological Health released a new guidance called Administrative Procedures for CLIA Categorization. The CLIA Categorization guidance discusses how a company should submit their devices to FDA to categorize the product. The categorization of the device is usually decided within 30 days of the original request. The guidance also explains how devices only qualify for waivers if they have been approved under a PMA or cleared via the 510(k) pathway. Devices with low-complexity are generally the type of devices that qualify for a waiver.
For more information, view the full article: New FDA Guidance Explains the Ins and Outs of the CLIA Categorization Process for IVDs.