Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the Washington, DC, office, was quoted in an article titled "FDA Targets 'High-Risk' LDTs In Notice Outlining Regulatory Framework."
Following is an excerpt:
FDA unveiled a preliminary risk-based plan for regulating laboratory-developed tests that puts an immediate focus on high-risks LDTs which will be regulated as Class III medical devices, outlining the framework in a notice sent to lawmakers Thursday (July 31) that pledges issuance of a draft guidance in at least 60 days. The notice, which says LDTs will fall under the existing device classification system, was praised by a major medical diagnostics group, patient advocates and Democratic lawmakers, but criticized by the American Clinical Laboratory Association (ACLA), which has led the charge against FDA regulation of LDTs in favor of continued CMS oversight.
Bradley Merrill Thompson, an attorney with Epstein, Becker & Green, praised the approach saying FDA clearly took into account the risks associated with clinical use of a test and also the more broad public health concerns such as unmet medical need and rare conditions. But ACLA expressed concern that "another layer of regulation could stifle diagnostic innovation" and jeopardize patient access to treatments.
