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

The commenter, a workplace substance abuse testing program administrator, supports the proposal to exempt certain Class II medical devices from premarket notification. They argue that the current regulatory process is overly bureaucratic and that the FDA should allow for easier adoption of saliva testing to improve workplace safety and efficiency.

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.

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.

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.

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.

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.

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.