Linda Malek and Jason Johnson are partners in Crowell’s Health Care and Privacy & Cybersecurity Groups, and have a particular focus on advising clients on compliance issues related to clinical research and clinical trials. Stephen Holland is Senior Counsel in Crowell’s Government Affairs Group and previously served as Senior Health Counsel to the U.S. House Committee on Energy and Commerce, where he advised on FDA policy, including legislation related to medical devices and laboratory developed tests.

The FDA has provided answers to the most common questions it has received regarding its final rule on laboratory developed tests (LDTs) (the “Final Rule”).  The answers are styled as FAQs that are organized by topic areas.  The FAQs can be found here.  If there is a question that is not answered, the FDA encourages individuals to submit questions to the FDA through the mailbox at ldtfinalrule@fda.hhs.gov.  The FDA notes that it intends to update the FAQs periodically so entities should check the webpage often for additional answers. 

As noted in our client alert regarding the Final Rule, the Final Rule marked a monumental shift in the diagnostic testing regime in the United States and has created a significant amount of questions around compliance and enforcement.  The FAQs provide some insight into FDA’s thinking on certain questions, which should help entities in their implementation of, and compliance with, the requirements of the Final Rule.

For example, the FDA has received a significant number of questions around its enforcement discretion, which are contained within the “Phaseout Policy and Enforcement Discretion Policies” section.  The questions range from very general (e.g., “I am a laboratory with an LDT. Do any enforcement discretion policies apply to my LDT?”—yes, so long as the LDTs are not modified following issuance of the Final Rule) to very specific (e.g., “Do LDTs with NYS CLEP [New York State Clinical Laboratory Evaluation Program] approval fall within an enforcement discretion policy in the phaseout policy? What if another lab offers an LDT that is not approved by NYS CLEP but is similar to an LDT approved by NYS CLEP – would it fall within the enforcement discretion policy for LDTs approved by NYS CLEP?”—yes, but the enforcement discretion applies only to the version of the LDT approved by NYS CLEP).  

Entities developing LDTs should prioritize review and monitoring of these FAQs to have the most up to date and relevant information from the FDA as they prepare for potential enforcement during the phase-in period laid out in the preamble to the Final Rule.

Crowell Health Solutions is prepared to assist with questions regarding the Final Rule and LDTs, including compliance planning and monitoring for additional developments at FDA. Please reach out with any questions.