The U.S. Food and Drug Administration (FDA) recently published a potentially transformative proposed rule dealing with in vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs). Specifically, the proposal aims to regulate IVDs, including LDTs, as medical devices. This marks a significant shift in the regulatory landscape for LDTs.
Part of this ruling’s importance lies in the proposed updates to the definition of IVDs within 21 CFR § 809.3. Practically, such an update would involve adding explicit language indicating that IVDs and LDTs are considered medical devices under Section 201(h)(1) of the Food, Drug, and Cosmetic Act (FDCA).
As legal professionals with interests in healthcare and regulatory law, this proposal, if accepted, may have notable implications for your work. Notably, the incorporation of LDTs as medical devices under the FDCA could mean more stringent oversight, meriting careful consideration of its potential impacts.
Going forward, close monitoring of the developments relating to this proposal will be essential for healthcare-focused legal firms and corporations. The regulatory landscape around IVDs and LDTs could be set for significant alteration pending the final decision on this proposed rule.