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

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.

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.

Easler Education LLC, a training and compliance organization for workplace drug and alcohol testing, supports the FDA's proposal to exempt certain Class II clinical toxicology devices from 510(k) requirements. The commenter argues that the exemption will reduce regulatory burdens and clarify confusion between FDA and SAMHSA requirements, but they urge the FDA to ensure the framework is broad and flexible enough to accommodate all federally regulated analytes and specimen types.

The National Drug & Alcohol Screening Association (NDASA) supports the FDA's proposal to expand 510(k) exemptions for certain Class II medical devices to reduce regulatory burdens on the drug testing industry. They argue that workplace drug testing is a forensic public safety mission rather than a clinical diagnostic one and urge the FDA to further transition oversight to the National Laboratory Certification Program (NLCP).

The Substance Abuse Program Administrators Association (SAPAA), a nonprofit trade association, supports the FDA's proposal to exempt certain Class II clinical toxicology devices from premarket notification requirements. They argue that the current regulatory uncertainty hinders the adoption of federal oral fluid drug testing and recommend that the final framework be broad and flexible enough to accommodate emerging drug trends and existing federal testing standards.

ARK Diagnostics supports the proposed expansion of Class II 510(k) exemptions for certain clinical toxicology test systems used in employment and insurance testing. They argue the proposal reduces unnecessary regulatory burdens for well-established assays and request further clarification on the scope regarding fentanyl assays and labeling requirements.

Chemtron Biotech, Inc. argues that certain opiate test systems, specifically those for Fentanyl and its analogs, should not be granted 510(k) exemptions. The commenter expresses concern over the lack of standardized cutoff levels and the technical challenges in distinguishing between specific isomers and emerging analogs.