Comment from Patrice Kelly

Summary: Patrice Kelly Consulting, LLC, representing clients in the commercial transportation and workplace drug testing industries, supports the proposed exemption of certain Class II clinical toxicology test systems from premarket notification requirements. However, the commenter argues that the proposal does not go far enough and urges the FDA to remove 510(k) requirements for the full scope of Federal drug testing, citing the existing SAMHSA National Laboratory Certification Program as sufficient oversight.