Medical Devices; Exemptions From Premarket Notification: Certain Class II Devices; Request for Comments

FleetSafe Solutions, a safety compliance consulting firm for the transportation industry, supports the full removal of the 510(k) clearance process from reagents and assays used in Federal drug testing. They argue that the current 510(k) requirements are overly onerous and have prevented the implementation of DOT-regulated oral fluid testing, which they believe is necessary for improving transportation safety.

Accredited Drug Testing, a provider of drug and alcohol testing services, supports the proposal to exempt certain Class II clinical toxicology test system devices from premarket notification requirements. The company argues that the current 510(k) clearance process for reagents/assays hinders the certification of oral fluid testing for Federal purposes and advocates for SAMHSA to provide the sole oversight for these tests.

Colorado Springs Utilities, a municipally owned utility provider, supports the FDA's proposal to exempt certain Class II clinical toxicology test system devices from premarket notification requirements. They argue that the current 510(k) requirements delay the implementation of oral fluid testing in the transportation industry and that the exemption will reduce regulatory burdens on the medical device industry.

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.

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 rigorous oversight of SAMHSA’s National Laboratory Certification Program.

The commenter, a founding member of the National Drug and Alcohol Screening Association (NDASA), supports the proposed expansion of 510(k) exemptions for certain Class II medical devices. They argue that the current FDA regulatory pathway is a mismatch for forensic workplace drug testing and advocate for transferring oversight to the National Laboratory Certification Program to improve public safety and modernize testing.

Janet Kornmann, a board member of the National Drug and Alcohol Screening Association (NDASA), supports the FDA's proposal to expand 510(k) exemptions for certain medical devices used in workplace drug testing. She argues that the current clinical device framework is a structural mismatch for forensic testing and urges the FDA to eventually transfer oversight authority to SAMHSA and the NLCP.

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.

InOut Labs, a national consortium and third-party administrator for DOT drug and alcohol testing, supports the FDA's proposed expansion of 510(k) exemptions for medical devices. The commenter argues that the current FDA clinical pathway is ill-suited for forensic workplace testing and urges the FDA to eventually transfer oversight of these specific technologies to SAMHSA and the NLCP.