On Jun 28, 2024, SCOTUS overturned the Chevron doctrine, which means that courts will no longer automatically defer to agency expertise when interpreting ambiguous laws. This ruling has significant implications for the Chevron doctrine, a legal precedent that has guided how courts defer to federal agencies' interpretations of ambiguous statutes for nearly 40 years.
The ruling transfers more interpretive power from federal agencies to the judiciary. Courts will now have greater authority to independently interpret statutes without necessarily deferring to agencies like the FDA. The agency will face increased scrutiny and potential challenges to its regulatory actions. This change will likely lead to a litigation surge as courts and litigants test the boundaries of this new judicial authority.
How will this impact the LDT rule? It was highly anticipated by the LDT industry and the agency that the LDT rule would be challenged in courts. The American Clinical Laboratory Association (ACLA) filed a lawsuit against the FDA in response to the agency's final rule issued on May 6, 2024, which aims to regulate laboratory-developed tests (LDTs) as medical devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This legal action, filed in the U.S. District Court for the Eastern District of Texas, argues that the FDA's rule overreaches its authority and misclassifies professional laboratory testing services.
The Chevron ruling means that courts will not automatically defer to federal agencies for interpretation. The LDT regulations essentially define IVDs as devices under the FD&C Act when the manufacturer is a laboratory. The agency appears to have been very careful in establishing the regulations in anticipation of legal challenges. The agency has also accumulated data over several years to support its position. Courts will now decide if they agree with the FDA that IVDs are devices under the FD&C Act if the manufacturer is a laboratory. It is also possible that courts may defer to the legislative branch to pass the VALID (Verifying Accurate Leading-edge IVCT Development) Act or similar legislation. Regardless of the outcome, we will likely see more litigation and challenges.
David Heffelfinger joined AltaQ in December 2017. Prior to AltaQ he was Site Manager & Senior Director of Engineering for QIAGEN. As VP Engineering at PrimeraDx (acquired by QIAGEN), David contributed to a highly successful 501K submission and clearance by the FDA. In addition, he was an engineering executive at Beckman Coulter, BD Biosciences, and Bio-Rad Laboratories as well as at several startups and venture capital-backed companies including Biometric Imaging, Alpha Innotech Corp, and Luminys Systems. Dave was also a founder of his own company, Hyperspectra LLC. He has a B.S./M.S. in Physics from Wayne State University and an M.B.A. from Saint Mary’s College (Moraga CA).
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Zain earned his BS in Bioengineering from Northeastern University in Boston. He also received the Designing and Building AI Products and Services certificate from the Massachusetts Institute of Technology (MIT).
Zain completed Engineering Co-Ops with EyeCool Therapeutics and Suono Bio where he supported clinical and product development.
Zain is pursuing his Master’s degree in Molecular Engineering at the University of Chicago.
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Fayyaz Memon has over 30 years of regulatory, quality and clinical experience in the IVD/LDT, medical device, and biotech industries. Fayyaz held progressive roles at a number of companies, including Natera, Biological Dynamics, Asuragen, Qiagen, PrimeraDx, ThermoFisher, Innovative Neurotronics, Digene, Pfizer, and J&J.
He has built a unique professional portfolio combining his QA/RA expertise with clinical, manufacturing, software, operations, and project management experience. He has a successful track record in guiding multiple companies to achieve regulatory approvals and successful commercialization.
Fayyaz has completed regulatory projects in the USA, Europe, and Asia. Fayyaz received his M.S. in Engineering and his M.B.A. from Drexel University.
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David Liu has over 12 years of quality and regulatory experience in the IVD/LDT and medical device industries. Prior to AltaQ, David established the quality department at Biological Dynamics and successfully obtained ISO 13485 certification. David contributed towards technical files for successful regulatory submission as well as FDA breakthrough device designation. He has a B.S in Chemistry from UNC-Chapel Hill and a PhD in Chemistry from University of Florida.
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