How Does FDA Regulate Direct-to-Consumer Tests

How Does FDA Regulate Direct-to-Consumer Tests

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In today’s video, we discuss how FDA regulates direct-to-consumer tests, tests that are marketed directly to consumers without the involvement of a health care professional, like the patient’s medical doctor.  Usually, these tests require that consumer to collect a saliva or urine sample, specimen and send it to the lab for analysis.

Many of our clients have asked us this question, as healthcare startups are expanding their marketing of tests the consumer can do at home, notably COVID-19 test.  This has become a huge area recently with the coronavirus.

I’m Michael H. Cohen, founding attorney of the Cohen Healthcare Law Group. We advise healthcare industry clients on how to navigate healthcare and FDA legal issues and as a result, launch and grow their health and wellness product or service.

The first thing to know is that, while we are going to focus this video on FDA regulation of direct-to-consumer lab tests, there’s much more you’ll want to know if you’re a healthcare startup that wants to market tests to your customers, with or without the involvement of a licensed medical doctor – and we address many of those issues in other videos.

For example, whenever a business arrangement provides an incentive for the physician to refer the patient to a particular lab and the physician profits from that referral, this potentially could be considered an unlawful kickback.

And where you have potential kickback issues, you also have potential violations of the prohibition against corporate practice of medicine.

Also, when you market testing, your claims have to be truthful and non-misleading.  Otherwise the Federal Trade Commission, the FTC, can launch an enforcement action based on false and deceptive advertising, not fun.  State attorneys general can jump on the litigation bandwagon, and so can private plaintiffs.

Again, we address these issues in other videos.  But now for the FDA fundamentals.  A lot of direct-to-consumer testing involves genetic testing; some involves levels of proteins or even bacterial flora, like the microbiome.  Many functional medicine doctors look to the microbiome for data about the patient’s overall health.

The key FDA rule here is that in vitro diagnostic tests, or IVDs, are considered Medical Devices.  Whether or not the tests are subject to rigorous regulatory requirements depends a lot on their level of risk.

For example, FDA probably will not review your direct-to-consumer test if you are promoting the test for non-medical, general wellness, or very low risk medical purposes.

On the other hand, if you are offering the test for moderate to high-risk medical purposes, like a COVID-19 test, then FDA generally will want to review your test to determine the validity of the claims you make. Of course this is all a moving target right now.

So you can have the same exact test, but depending on whether you make claims that are: (a) non-medical, general wellness claims or claims for medical purposes that are low-risk, or (b) claims that involve moderate to high health risk, you might be within or outside FDA’s purview and review, respectively.

And also, FDA looks at whether the test offers accurate descriptive information that can easily be understood by a consumer without the involvement of a health care provider. If it can, then the test likely can be sold direct-to-consumer without FDA review.  And if can’t, then you need FDA review, and, the test is likely considered a medical device.  Even if it is a medical device, some medical devices are exempt from FDA premarket review, although they have to fit specific regulations.

Again, Direct-to-Consumer tests are a very complex and rapidly evolving arena. We look forward to speaking with you again soon.


  • I would definitely recommend. I needed direction regarding the FDA and how the rules would affect my business. Responsive, accessible, and knowledgeable.

    Richard Freedland
    Richard Freedland GRAMedical, CEO
  • Impressive credentials are only overshadowed by their clear awareness of practical strategies to help Physicians navigate modern healthcare and achieve successful outcomes.

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    James Riviezzo Practice On Your Terms

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