Comment from R. H. Barry Sample, Ph.D.

Summary: Dr. R. H. Barry Sample, a professional with extensive experience in clinical toxicology and IVD manufacturing, supports the FDA's proposal to expand 510(k) exemptions to include devices for Federal drug testing programs. He argues that the current exclusion creates market uncertainty and advocates for specific improvements, including broader analyte coverage, inclusion of oral fluid collection devices, and formal recognition of SAMHSA and NLCP as governing authorities.