Comment from Clinical Reference Laboratory, Inc.

Summary: Clinical Reference Laboratory, Inc. (CRL), a high-volume laboratory provider, supports the FDA's proposal to remove the exclusion of devices intended for Federal drug testing programs from Class II premarket-notification exemptions. They argue that these tests are not diagnostic and are already subject to robust independent safeguards, and they request specific clarifications to ensure the exemption is broad enough to cover all eligible test systems and matrices without unnecessary product-code limitations.