On October 3, the US Food and Drug Administration (FDA) initiated a proposed rule in a bid to expand its regulatory oversight of in vitro diagnostic products (IVDs), including laboratory-developed tests (LDTs). The FDA, in the proposed rule, stated its intention to amend its regulations such that these LDTs are officially recognized as medical devices under the federal Food, Drug, and Cosmetic Act (FDCA).
According to the details of the proposed amendment, all regulations corresponding to medical devices under the FDCA would apply to these LDTs. Such a recognition and the resulting regulatory expansion by the FDA would necessarily mean increased requirements and regulations for legal professionals working in the health sector, particularly those representing laboratories and medical device companies.
Laboratory Developed Tests, up to this point, have enjoyed a degree of independence from the FDA’s oversight and this new move, if implemented, will signal a significant alteration in their governance. The implications for the healthcare industry and specifically for legal professionals in this sector could be far-reaching, as compliance requirements could increase and innovation within the space could face new challenges.
Legal professionals are being urged to stay informed and prepared as the potential impact on the regulatory landscape could necessitate substantial adjustments to current compliance protocols within the IVD and LDT spaces. As yet, reactions from the industry to these proposed changes are still being assessed.