Broadly speaking anything can be used for an LDT as long as the laboratory has appropriate validation, so that means the test would need to be validated by the performing laboratory including the collection device. The LDT space is a little grey from a regulatory standpoint, and in my opinion the use of an RUO home collection device (vs. an FDA-cleared/approved one) raises the risk of FDA taking an interest. As long as the test is validated and performed in a CLIA laboratory, you can report results.
There is a sharp dividing line between LDTs and IVDs (including ROUs and IUOs).
Historically, FDA exercised Enforcement Discretion over LDTs because they had limited use. A lab in a hospital needed to develop a specific test for a specific patient. While these test are medical devices, FDA, correctly in my opinion, decided that regulating them is not in the public interest.
The large commercial labs utilized LDT Enforcement Discretion to commercialize some of there tests. They claimed that since the lab developed the test and ran the test in its facility, it was similar to the case above. CLIA, which regulates testing in the labs stepped in and said that the LDTs require a high complexity lab. CLIA only regulates the testing portion, not the design, development, and production.
FDA learned of numerous problems with the medical devices developed by these labs and recognized that it was time to regulate these tests. I characterize the problem in simple terms. On a block in a certain city there is a company that markets a certain test for use in labs. These tests are regulated by FDA to ensure safety and effectiveness. One the same block is a CLIA high complexity lab that decides to produce a similar test as an LDT. The first test has the assurance of FDA review, the second test does not. FDA decided, correctly in my opinion, to provide the same level of control over both tests.
The subject came to head with 23 & Me, when FDA "shut them down" because of Direct to Consumer" DTC, tests. For a long time 23 & Me offered only tests related to ancestry until FDA cleared their tests.
Today, the situation is, in my opinion, murky. The Trump administration decided that there should not be any new regulations unless proved necessary. In addition, by Executive Order. Every new regulation requires the repeal of two existing regulations.
FDA withdrew the intent to regulate LDTs.
Currently, there is a bill in Congress to change FDA's regulatory authority over LDTs, IVDs, and other diagnostic tests. It has been through a number of iterations. FDA is on record that if it does not pass in a reasonable time, FDA will regulate LDTs.
Moving away from LDTs, the regulatory structure for IVDs is important. All of this is in 21 CFR Part 809. The starting point is that an IVD is a medical device with distinguishing characteristics.
As a medical device, IVDs follow 21 CFR Part 809. IVDs in general must follow Part 812 Investigational Device Exemption. However, there are exceptions in 812.2(c).
If the IVD is in the laboratory research phase of development, and not represented as an effective in vitro diagnostic product, then it is an RUO and labelled this way.
If an IVD is shipped or delivered for product testing prior to full commercial marketing, then it is an IUO and labelled this way.
If you have submitted a request to FDA for clearance or approval, then it cannot be an IDE, ROU, or IUO. You should have completed these phases and included the data in your submission.
If you claim it is an LDT, that implies you do not intend to submit it as an IVD.
Also, based on the description, your device may be DTC. I n this case you should read all the Warning Letters to 23&Me, Quest Diagnostics, and LabCorp. All have faced this problem.
My recommendation is that you declare a dichotomy between LDT or IVD. I suspect that management would like the revenue by blurring the distinction, but FDA enforcement action would consume that revenue.
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Dan O'Leary CQA, CQE
Swanzey NH
United States
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Original Message:
Sent: 19-Apr-2023 16:48
From: Anonymous Member
Subject: LDT test / RUO
This message was posted by a user wishing to remain anonymous
So to summarize, you're using an RUO collection device for home collection, shipping the specimens to a central CLIA laboratory certified to perform high complexity testing, and running the samples on an LDT. Correct?
Broadly speaking anything can be used for an LDT as long as the laboratory has appropriate validation, so that means the test would need to be validated by the performing laboratory including the collection device. The LDT space is a little grey from a regulatory standpoint, and in my opinion the use of an RUO home collection device (vs. an FDA-cleared/approved one) raises the risk of FDA taking an interest. As long as the test is validated and performed in a CLIA laboratory, you can report results.
Original Message:
Sent: 18-Apr-2023 13:30
From: Anonymous Member
Subject: LDT test / RUO
This message was posted by a user wishing to remain anonymous
Hello,
I've had minimal experience in dealing with LDT test. Our company is an IVD manufacture with our first class III IVD under PMA review, our test is considered high complexity under CLIA. Our commercial department wants to run an Early Access Program (EAP) on about 200 patients to test our commercial platform works before we get our approval. In order to complete this, they want to contract with a few physicians offices who will get informed consent from their patient, prescribe the test, we ship device to patients home for specimen collection, they ship back to our CLIA lab for processing, and then we provide physical with test result. The test for this "program" will be LDT and the specimen collection device will be labeled RUO. It was my understanding that results cannot be reported to the patient's physician or medical record and cannot be used to assess the patient's condition or for any diagnostic, prognostic, monitoring, or therapeutic purposes when using and RUO device. But because they are going to be using LDT test, would this be okay to provide physical results. Thanks for sharing any expertise in this subject.