Despite a determination by the Department of Health and Human Services (“HHS”) that laboratory developed tests (“LDTs”) do not require premarket approval, the Food and Drug Administration (“FDA”) has asserted that the at-home collection kit portion of a COVID-19 LDT does require FDA pre-market approval.
Testing by clinical laboratories is regulated by the FDA and by the Clinical Laboratory Improvement Amendments (“CLIA”), as administered by the Centers for Medicare & Medicaid Services (“CMS”). The FDA regulates medical devices, including in vitro diagnostic products (“IVDs”). The FDA considers LDTs to be IVDs that are intended for clinical use and are designed, manufactured, and used within a single laboratory. CLIA, on the other hand, regulates the laboratory itself and classifies LDTs as “high complexity tests,” with corresponding standards imposed on the laboratory. Importantly, regarding the LDT itself, CLIA requires only analytical validation, which can occur after testing has already begun. LDTs may also be subject to more stringent state and private sector oversight.
Historically, the FDA had exercised enforcement discretion and not regulated LTDs, but this began to change in recent decades. However, in August 2020, HHS directed that, absent rule and commenting and at least during the COVID-19 public health emergency, the FDA would not require premarket review and approval of LDTs. This allowed clinical laboratories to develop and begin using LDTs to test for COVID-19 without delaying for an FDA Emergency Use Authorization (“EUA”) or other approval. Some of these LDTs included at-home collection kits wherein the patient collected the sample at home, sometimes under the telemedicine supervision of a health care professional, and shipped it to the laboratory for testing.
However, the FDA has taken the position that all at-home self-collection kits, including those which are supervised via telemedicine, are medical devices distinct from the LDTs and thus require FDA approval. FDA approval may take the form of an EUA for the test itself that specifically authorizes at-home self-collection; however, many COVID-19 LDTs are properly being used without premarket approval and thus do not have EUAs. The FDA has cited concerns that patients, even under supervision, are unable to collect, package, and ship the sample in a way that maintains its integrity for testing. Moreover, the FDA has begun sending warning letters to laboratories that sell LDTs with at-home self-collection kits warning that the collection kits are not authorized for sale. This position appears at odds with both the text and the purpose of HHS’s August directive, although HHS has yet to publicly weigh in on the issue.
For over 35 years, Wachler & Associates has represented healthcare providers and suppliers nationwide in a variety of health law matters, and our attorneys can assist providers and suppliers in understanding new developments in LDT regulation. If you or your healthcare entity has any questions pertaining to healthcare compliance, please contact an experienced healthcare attorney at 248-544-0888 or wapc@wachler.com.