LAB DEVELOPED TESTS – FDA Working on LDT Guideline: Implications & Questions


In the past several years, it seemed that a cry for regulation of Lab Developed Tests (LDTs) was falling on deaf years at the FDA. However, after a thorough and intricate letter from the Senate and public outcry for regulations, it seems that the FDA is finally taking action. After serving the 60-day legal notice to congress, the FDA has finally begun the process of setting rules for the regulation of LDTs.

The past several weeks after the FDA’s announcement, there has been a range of reaction from the public. There are many who are relieved about this decision for stricter regulation in a previously uncontrolled segment of the healthcare. However many of the corporate companies are uncomfortable, to say the least, regarding this situation. They are unsure about the consequences this could potentially pose on their revenues and position in the market. The FDA has already forewarned these companies that this is going to be a long and arduous process, especially when there are about 11,000 LDTs currently offered by over 2,000 labs. Many are unsure and unaware of what the regulation process could look like, so here is a quick overview of what it might entail:


The FDA is going to use a similar protocol to the regulation imposed on the IVD industry. Here is a quick overview of the regulations for the LDTs. The FDA is using a risk-based classification approach similar to the IVD market. Class I devices, which are subject only to general controls, generally represent the lowest-risk category of devices, while Class III devices, which are subject to general controls and premarket approval, generally represent the highest-risk devices.

There is very little regulation or the FDA intends to exercise enforcement discretion for the class I LDT products, which are low-risk LDTs; LDTs for rare diseases and traditional LDTs that existed when the enforcement discretion policy was initially implemented; and finally there are the LDTs for unmet needs that will receive enforced discretion when there are no other FDA-approved or cleared equivalent devices available.

This is a different ball-game when looking at moderate (Class II) and high-risk (Class III) LDTs. Adverse reporting begins at the 6 months mark after the guidance is finalized. And the pre-market review will only begin after the high-risk (Class III) LDTs are completed. The high risk LDTs (Class III), where registration begins at the reporting begin 6 months after the finalizing the guidance and pre-market review will occur after a year. One of the other requisites to this regulatory framework is the emphasis on the use of clinical studies for validation of their products. These regulations will have serious implications for these labs. Some are as follows:

Increased Competition – One of the implications of this regulation is that it is going to create tough competition between these labs due to the interference of the FDA in approving each of these products. This industry is going to change and replicate to a similar system seen in the IVD industry. Once the rules are in place, the FDA is going to receive a huge influx of application for the LDT products and the backlog for approvals is going to significantly affect these labs in terms of delayed revenues.

Accessibility of the Products & Lack of Innovation – The FDA is already under a lot of pressure from the different industries with regard to regulation. The time it takes to review each of these products even though necessary, takes a phenomenal amount of time. The decreased efficiency in product launches to patient care is of concern to many. Many pathological procedures developed by the labs have had enormous impact in patient care in diverse fields from oncology to infectious diseases. These slow approval processes could really impede accessibility to the patients in terms of availability and cost of the products.

In a similar vein, due to these additional layers of regulatory protocols those are required for labs to follow. There is concern that this would impede innovation and development of products and the practice of medicine. The FDA regulation is needed for LDTs despite their impact in the medical field. The lack of it had its own set of consequences that cost lives. Hopefully, with efficient regulation of the LDTs, there will be a chance for a more ideal form of patient care for the future.

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Aish Vivekanandan is an Industry Analyst with Frost & Sullivan’s Global LifeSciences practice. She has extensive industry knowledge identifying emerging technologies and tracking technological and market developments across the life sciences domain. She has particular expertise in drug discovery technologies and tools, and clinical and in vitro diagnostics. For more information about Frost & Sullivan’s global Life Sciences practice, email Jennifer Carson, Corporate Communications at