Header: FDA wants an elaborate assessment of your LDT validity by May 2026 and will "take action" against any claims that are not substantiated enough, in the eyes of the FDA. This includes NY State and Grandfathered tests.
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On April 29, 2024, FDA announced its final rule for regulating LDT's over a period of several years (a staged roll-in). In Stage 2, by May 2026, FDA expects compliance with all "labeling" requirements.
Remember that for drugs and devices, "labeling" is not just the outside of a box, but the full instructions for use and validated clinical support data which underlie "claims." Drug advertisements are cautious not to make "claims" that aren't supported by labeling (package inserts, etc) which have been scrutinized by FDA. (There are some exceptions related to first amendment.)
FDA has an elaborate website for its LDT regulatory plans - https://www.fda.gov/medical-devices/in-vitro-diagnostics/laboratory-developed-tests
Amid the lengthy webpage, don't miss the little link for FAQs:
https://www.fda.gov/medical-devices/laboratory-developed-tests/laboratory-developed-tests-faqs
Here's the FAQ for labeling. Remember, being an New York State-approved or a "grandfathered" test only relieves the lab from a 510(k) or PMA submission - it doesn't relieve the lab from the 2026 requirements like "labeling." And you can't just have "labeling" on file - it has to be summited to FDA. For example, for the Pillar "Onco Reveal" test, PMA 200011, the safety and effectiveness is 45 pages long, while the "labeling" for labs is 85 pages long and even the "physician" labeling is 8 pages long (with several pages for detailed test performance characteristics).
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Q: FDA states that the Agency intends to request submission of labeling for certain IVDs offered as LDTs. What does this mean, and what is the scope of FDA review of this labeling?
A: For IVDs that fall within the NYS CLEP, unmet needs or “currently marketed IVDs offered as LDTs” (i.e., those that were first marketed prior to May 6, 2024) enforcement discretion policy, FDA intends to request that manufacturers submit certain labeling information to the Agency in connection with the listing of the IVD as provided in 21 CFR 807.26(e).
Labeling includes IVD performance information and a summary of supporting validation, as applicable. This information will help FDA more closely monitor currently marketed IVDs offered as LDTs and identify those that may lack analytical validity, clinical validity, or safety.
As part of its review of labeling for currently marked IVDs offered as LDTs, FDA intends to look closely at claims of "superior performance" and whether those claims are adequately substantiated.
FDA generally intends to take action where the labeling of a currently marketed IVD offered as an LDT is false or misleading, and/or the IVD offered as an LDT lacks the appropriate assurance of safety and effectiveness for its intended uses as a result of any such claims that are not adequately substantiated.
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AI Corner
I am not an attorney, and that includes not being an attorney for FDA promotions and labeling law and case law. I did ask Chat GPT to weigh in, and include that below.
Chat GPT 4 writes:
The FDA views claims made in advertising or promotional materials as "claims" if they represent the product's attributes, effects, or benefits. These claims must be supported by validated data that has been reviewed and approved by the FDA for inclusion in the product's official labeling. If promotional claims exceed what is validated and approved by the FDA, they may be considered misleading and could result in regulatory action. Therefore, companies must ensure that all claims in their promotional materials align with the approved labeling and are supported by robust evidence.
Are there some exceptions under First Amendment or for publications? For example, can I make an advertising claim substantiated by a new New England Journal article?
While the First Amendment protects free speech, including commercial speech, the FDA maintains stringent regulations on advertising claims for drugs and medical devices to ensure they are not misleading and are supported by substantial evidence.
Even if a claim is substantiated by a new article in a reputable journal like the New England Journal of Medicine, it cannot be used in advertising unless it is consistent with the FDA-approved labeling. Here are some key points regarding exceptions and publications:
First Amendment Considerations: While the First Amendment protects commercial speech, this protection is not absolute. The FDA can regulate commercial speech to prevent misleading or false claims, ensuring public health and safety.
Scientific Publications: Manufacturers can disseminate peer-reviewed scientific journal articles that discuss off-label uses, but this dissemination must be done in a non-promotional context and should follow specific guidelines set by the FDA.
Promotional Claims: Any promotional claim, even if substantiated by new research, must be consistent with the FDA-approved labeling. If a new study supports a claim that is not included in the labeling, the manufacturer must seek FDA approval to update the labeling before using the claim in advertising.
Dissemination of Information: The FDA allows certain scientific information to be shared with healthcare professionals, provided it is balanced and not misleading. This includes reprints of peer-reviewed scientific articles, which should be distributed in a manner that does not appear promotional.
In summary, while new scientific articles can inform clinical practice and be shared in educational contexts, advertising claims must remain within the boundaries of FDA-approved labeling to ensure they are not misleading.
