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

Lifeloc Technologies Inc., a manufacturer of alcohol breathalyzers and drug testing equipment, supports the FDA's proposal to exempt certain Class II devices from the premarket 510(k) notification process. The company argues that this change will reduce costly regulatory hurdles and benefit smaller companies by accelerating the commercialization of testing devices.

Omega Laboratories, Inc. supports the proposed FDA exemption for certain Class II clinical toxicology test system devices, arguing that workplace drug testing is a forensic rather than a clinical diagnostic process. They advocate for a regulatory framework that recognizes existing forensic quality systems (like CAP and ISO) to avoid duplicative and costly federal certification regimes.

Abbott Laboratories supports the FDA's intent to exempt certain Class II clinical toxicology test system devices from premarket notification requirements. They argue that existing performance and validation testing for federal drug testing programs already ensures safety and effectiveness, while also recommending clarifications on collection systems and a modernization of product codes.

Julie Herron, an Employee Relations Administrator for the San Mateo County Transit District, supports the FDA's proposal to remove the exclusion for certain Class II clinical toxicology test systems from the 510(k) exemption. She argues that the change reduces unnecessary regulatory burdens and costs for manufacturers and employers while maintaining adequate safety controls for devices used in Federal drug testing programs.

Alison Thierry-Hunt, President of Allied Safety and Health, LLC, supports the FDA's consideration to exempt certain Class II clinical toxicology devices from premarket notification. The commenter argues that the current 510(k) clearance requirement creates unnecessary barriers for drug testing and collection devices to enter the federal marketplace.

OMS Compliance Services, a C/TPA, supports the 510(k) exemption for DOT collection devices to facilitate oral fluid collections. They argue that this less invasive procedure will reduce labor costs, eliminate the need for same-sex collectors in certain scenarios, and improve efficiency for employers in tourist-heavy areas.

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.

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.

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.