James A. Boiani, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in 360Dx, in “At-Home Tests for Influenza, Strep, Others Raising Eyebrows of Some Experts,” by Madeleine Johnson. (Read the full version – subscription required.)
Following is an excerpt:
Several diagnostic test kits marketed for home use or at-home sample collection are raising the eyebrows of laboratory experts worried about their safety to consumers and questioning whether they may be violating US Food and Drug Administration regulations.
Such kits have not been cleared by the FDA for the indications they are being marketed to, and whether they are technically in violation FDA regulations is murky. For some in the industry, such tests may pose a risk to patients, yet the firms assert that they are compliant with all state and federal regulations, and other experts suggest that the telephone or video conferencing with physicians provided with the test kits may satisfy requirements for physician ordering and oversight of diagnostic testing. …
However, there seems to be a consensus among experts that the crux of the matter lies in the use of the telemedicine model.
“It is possible that these companies would argue the tests are being provided pursuant to physician practice of medicine, which FDA does not regulate,” said James Boiani, an IVD, drug, and medical device life sciences attorney at Epstein, Becker & Green in Washington, DC.
The companies might also argue that if a patient is performing the test “under the physician’s observation and direction,” such as through a telemedicine consult, then this might be compliant with that particular physician’s Certificate of Waiver from CLIA for his or her office practice, Boiani said.