68 FOGHORN The bottleneck has been the Food and Drug Administration(FDA). Its 510(k) medical device clearance requirement was built for hospital diagnostic equipment, and it has blocked the laboratory infrastructure that federal drug testing programs need. This spring the FDA finally moved. On May 1, it published a Notice of Intent at Docket No. FDA- 2026-N-4268 to exempt these devices from the 510(k) requirement. On June 29, I signed PVA’s formal comments backing the proposal and pushing FDA to finish the job: cover the full federal testing panel including PCP, cover the oral fluid collection devices themselves, make existing inventory usable immediately, exercise enforce- ment discretion in the interim, and formally recognize SAMHSA and the National Laboratory Certification Program as the governing authorities for this forensic testing framework. The American Waterways Operators filed parallel comments the next day. FDA faces a statutory 120-day dead- line, so a final determination is due by the end of August. One more point. This is a deregu- latory initiative. We are asking the federal government to eliminate a du- plicative clearance requirement that forces manufacturers to prove device performance twice, to two different agencies, under a framework never designed for workplace drug testing. PVA will always push for less regu- lation and more operator flexibility. This effort fits squarely within the administration’s own regulatory re- form agenda. The federal government has already decided that oral fluid testing is sci- entifically valid. Our job is to make sure the last barrier comes down. If outdated testing rules have cost you a good candidate, tell us. Those stories are the most persuasive advocacy we have, and PVA’s Legislative Commit- tee will continue to advocate for this member flexibility. Safe sailing. Sincerely, Andrew Sargis PVA President, 2026 Continued from page 4: Letter from the President AT THE HELM
View this content as a flipbook by clicking here.