FDA Responds to Question from CAP on LDT Oversight

The Food and Drug Administration (FDA) answered a question submitted by the CAP on the oversight of laboratory-developed tests (LDTs). The CAP has submitted more than 200 questions collected from pathologists and laboratories. Here is the FDA's response to one of those questions:

Question: There is confusion about the regulatory obligations for LDTs developed after the issuance dates. We have received many questions about how to classify the tests, what documentation is needed, and can laboratories bring these systems online now.

Answer: FDA classifies in vitro diagnostics (IVDs) manufactured by laboratories, including laboratory developed tests, in the same way it does other IVD test systems.

Test systems are a set of components—such as reagents, instruments, and other articles—that function together to produce a test result. Test systems include components and are accompanied by instructions for use for sample preparation and pre-analytical processing. Classification of the test system is based on the intended use and risk of the test system.

The most efficient method for an IVD manufacturer to determine the classification of a device type that has already been classified by FDA is by searching the product classification database, included on the resources and references page of the webinar slide deck. Searching FDA's 510(k), premarket approval (PMA), and De Novo databases may also be helpful in understanding what specific IVDs fall within a given device type and how such IVDs are regulated.

An IVD may be of a type that has not already been classified by FDA and, therefore, would not be in the product classification database. As a reminder, device types that have not been classified by FDA previously, and that were not on the market prior to the enactment of the Medical Device Amendments on May 28, 1976, are automatically Class III unless they are reclassified by FDA. If an IVD has not been classified, manufacturers should assess the risk of their IVD and submit the appropriate premarket submission based on the assessed risk. If the manufacturer believes their IVD is high risk, a PMA is likely required. If the manufacturer believes their IVD is low or moderate risk, the IVD may be eligible for de novo classification. The de novo process provides a pathway to class I or class II classification for medical devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness, but for which there is no legally marketed predicate device.

FDA FAQ

The FDA hosts an FAQ page with answers to common questions about LDT oversight. If you cannot find the answer you're looking for, please contact FDA at LDTFinalRule@fda.hhs.gov.