Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Medical Device and Diagnostic Industry (MD+DI), in “5 Bold Predictions for Medtech in 2016.”
Following is an excerpt:
That FDA will regulated laboratory developed tests (LDTs) is probably the least bold prediction for 2016. In November, the agency released a report showing 20 examples of LDTs having harmed or had the potential to harm patients. In vitro diagnostics (IVDs) are regulated by FDA while, LDTs, which are IVDs designed, made, and used in a single lab, are held to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) standards, overseen by CMS.
But “CMS … seems solidly behind the FDA proposal” said Bradley Thompson, member of the law firm Epstein Becker & Green who practices in the firm’s healthcare and life sciences practice. Thompson called this development significant.
While not part of the FDA report, the missteps at promising diagnostics startup Theranos outlined by a scathing Wall Street Journal has also brought to light the need for LDTs to be regulated.