Resources and Interactions with FDA: Laboratory Developed Tests FAQs
Additional Resources for Support
The FDA plans to hold educational webinars, publish guidance documents, provide templates, and participate in conferences. Any IVD manufacturer can also use the FDA's Q-Submission process to discuss considerations for specific IVDs.
A: Yes. Foundational to our approach is ensuring we are answering generally applicable questions in a manner that is transparent to the entire industry. To this end, FDA intends to hold additional webinars and will consider providing guidance and/or additional resources on specific topics, such as compliance with applicable labeling requirements, over the course of the phaseout period. To the extent FDA issues additional guidance, the Agency will do so in accordance with good guidance practice regulations.
A: If you have a question about a specific test, we encourage you to engage with us through the pre-submission process, which includes an opportunity for a meeting regarding such a test.
If, however, you have a general question where the answer is likely relevant to others, we encourage you to send it through our mailbox (ldtfinalrule@fda.hhs.gov). Rather than meeting with parties on these general types of questions, we have been addressing them, and providing other information, in a public manner, such as through guidance, webinars, and website FAQs. We have been doing this in the interest of fairness, efficiency, and transparency.
FDA Resources
A: FDA considered Agency resources in developing the final phaseout policy. The timeline for phaseout of the general enforcement discretion approach for premarket review aligns with the next reauthorization of MDUFA. This alignment will provide an opportunity for FDA and industry to negotiate regarding user fees and performance goals with the knowledge that laboratory manufacturers will be expected to comply with applicable premarket review requirements. FDA will gain more visibility into the universe of IVDs offered as LDTs through R&L in stage 2, which should help the Agency facilitate the efficient allocation of resources for those IVDs.
FDA expects that the targeted enforcement discretion policies described in the preamble to the final rule will significantly reduce the number of IVDs that will come to FDA for premarket review compared to the proposed rule. FDA also intends to develop appropriately targeted enforcement discretion policies for certain common changes (like extension of reagent stability and certain alternative specimen types).
In addition, FDA anticipates that laboratories may seek to utilize FDA's Third Party Review Program, which FDA is currently working to enhance, as well as PCCPs that will reduce the number of future submissions for significant modifications.
In addition, on January 31, 2024, FDA announced its intent to initiate the reclassification process for most IVDs that are currently class III into class II. FDA aims to complete this reclassification process before stage 4 of the phaseout policy, which would allow manufacturers of certain types of tests to seek marketing clearance through the less burdensome 510(k) pathway.
A: As discussed in the webinar, oversight of IVDs is largely within the Office of In Vitro Diagnostics within the Center for Devices and Radiological Health (CDRH), with certain IVDs overseen by offices within the Center for Biologics Evaluation and Research (CBER). The staff in these offices have a broad range of technical expertise and a depth of experience overseeing IVDs, including LDTs, across a wide variety of methodologies and clinical focus areas. These staff members include those who have worked in clinical laboratories and developed LDTs, molecular pathologists, a genetic counselor, and PhD trained scientists. LDTs, like all IVDs, are overseen by the review division with expertise in that device type, ensuring that LDTs and non-LDTs for the same intended use are overseen by the same group.