I am a reimbursement expert, not an FDA expert, but I will point out to clients who ship proprietary (non-FDA) collection kits, the FDA has sometimes been adverse to those. (Not commonly.)
Zegarelli and Hawana of the Mintz law firm post an article about collection kits - titled, "FDA's Backup LDT Enforcement."
Find it here:
https://natlawreview.com/article/fdas-backup-ldt-enforcement-method-specimen-collection-kits
Pointed out by Heather Thompson at Linked In (here).
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AI CORNER
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AI summary.
TL;DR – Careful Summary of “FDA’s Backup LDT Enforcement Method: Specimen Collection Kits” (Mintz, March 13, 2025)
Even as FDA’s new rule to regulate laboratory-developed tests (LDTs) faces legal challenges, the agency has another powerful enforcement pathway: specimen collection devices and kits. These are separately regulated medical devices under existing FDA rules, even when used with LDTs.
Key Points:
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Specimen collection devices and kits (e.g., saliva tubes, lancets, dried blood spot cards) are considered in vitro diagnostic (IVD) medical devices, regulated independently of the LDTs they support.
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When multiple collection components are assembled and sold together (e.g., a branded home saliva kit), FDA considers this a “convenience kit” subject to device regulations, including establishment registration, labeling, quality systems, and sometimes 510(k) clearance.
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For at-home collection kits, FDA requires human factors data showing safe use by laypersons, often a high regulatory hurdle.
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Some labs and kit providers mistakenly assume these kits fall under LDT enforcement discretion—they don’t. FDA can target these kits even if LDT oversight is blocked or delayed.
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Noncompliant kits—such as those marketed for unauthorized uses or directly to consumers without clearance—are at high risk of enforcement, especially if tied to serious health conditions like cancer or infectious diseases.
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Clinical labs may face a Catch-22: to get a collection kit cleared, they must show it's safe with their specific LDT, but can't collect data without clearance—potentially exposing the LDT to FDA scrutiny.
Strategic Implication:
Regardless of what happens to the LDT final rule, the FDA can still enforce compliance by focusing on collection kits. Labs must ensure the kits they develop or distribute meet all applicable FDA device regulations—or obtain them from compliant third-party manufacturers. State agencies like New York CLEP are also emphasizing this requirement.
Bottom Line:
Specimen collection kits are a regulatory choke point for LDTs. Even if broader LDT regulation is stalled, FDA oversight of these kits is real, expanding, and enforceable now. Labs using or distributing them need a clear compliance strategy—or risk enforcement.