The FDA has been rolling forward with the implementation of the new medical device rules whereby the Lab Developed diagnostic Tests (LDTs) will be converted to conventional In Vitro Diagnostic (IVD) devices or removed from the market. It is the responsibility of the manufacturers of LDTs to navigate the new regulatory environment. A new page on FDA’s website lists the resources available from the FDA to these manufacturers.
The LDT industry enjoyed decades of no regulatory oversight. New tests were created and offered to patients without worrying about the FDA. Most of the LDT manufacturers have practically no experience submitting applications or interacting with the FDA. Since the FDA proposed the new IVD rule eilimating the LDT pathway, it has released a few guidance documents, created a transition timeline, and organized a few training webinars to help LDT manufacturers comply with the new requirements. The latest in that effort is a new sub-page on FDA’s LDT page with FAQs about the resources and interactions with the FDA. And this list is pretty short with only 4 questions. These questions link to the other pages on the LDT page which contain more details. The first three questions provide generic answers about the resources the FDA in creating to help the LDT manufacturers, namely guidance documents and webinars, presentations, and templates. The last question is the most interesting as it talks about the internal resources at the FDA to review all the new LDT applications expected to be submitted.
The LDT to IVD rule is the most controversial enforcement actions by the FDA. There a few legal challenges currently floating through the courts. This is a perfect case to test the post-Cheveon legal environment. So far, the courts have not stayed the FDA timelines for enforcement. For those who are waiting for a legal action to reverse the new FDA LDT requirements, time may be running out. It may be better to explore the regulatory solution rather than the legal one.
The best risk mitigation strategy is compliance with the rules while you wait for the legal process to play out. The assumption is that the companies which initiate regulatory interactions with the FDA early on would fare better over the long run. Some of the requirements such as the setting up a Quality Management System and initiating a pre-submission meeting with the FDA are good business practice for the LDT-IVD manufacturers anyway. It is prepared who weather the storms the best.
