Eli Y. Adashi & I. Glenn Cohen, Integrity of SARS-CoV-2 Laboratory-Developed Tests—Reply, 328 JAMA 478 (2022).
Abstract: We appreciate the comments by Dr Genzen and colleagues about our recent Viewpoint1 on SARS-CoV-2 LDTs. The FDA has long asserted its authority to regulate LDTs even while using its enforcement discretion to largely leave LDTs alone. Although many FDA law scholars believe the FDA’s authority to regulate at least some LDTs is well supported by the relevant statutory language,2,3 Dr Genzen and colleagues are correct that this view is not universally shared and that the issue has never been resolved in court. Although there have been past attempts to clarify this question through acts of Congress, the aftermath of the COVID-19 pandemic may underscore the importance of doing so.