Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs
In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory developed tests (LDTs). LDTs have historically not been subject to significant regulatory oversight, and while the FDA aims to promptly release the final rule on this intricate issue laden with complexities, potential roadblocks may delay its course of action.
Bridgette, Joanne, and Ben discuss this and also cover:
- What is a laboratory developed test (LDT)
- Where LDTs sit from a regulatory perspective
- What industry stakeholders are saying about these rules
- What the proposed rules mean
- Why the FDA is stepping in now
Read more about the public response to the proposed rules on our blog post, The LDT Debate: Unpacking Public Responses to FDA’s Proposed Rule.
Send in your questions to [email protected].
Authors
Bridgette A. Keller
Of Counsel
Bridgette advises health care providers, ACOs, health plans, PBMs, and laboratories on regulatory, fraud and abuse, and business planning matters, applying her experience in health system administration and ethics in health care to her health law practice.
Joanne S. Hawana
Member
Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.
Benjamin M. Zegarelli
Of Counsel
Benjamin advises pharmaceutical, medical device and biotech companies on the FDA regulatory process to identify the correct regulatory pathway, assisting with FDA communications and strategy.