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# FDA ‘Irresponsible’ in NIPT Safety Warning: Attorneys
- URL: https://www.fdaweb.com/fda-irresponsible-in-nipt-safety-warning-attorneys/
- Published: 2022-05-25T12:00:00.000Z
- Updated: 2026-09-14T17:46:16.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151901

Three Hyman, Phelps & McNamara attorneys say FDA was irresponsible in not providing specific evidence to support claims in a 4/19 safety warning about non-invasive prenatal tests (NIPT). Writing in their firm’s *FDA Law Blog*, the three [say](https://www.thefdalawblog.com/2022/05/fda-issues-safety-warning-regarding-non-invasive-prenatal-testing-raising-questions-about-the-future-of-fda-regulation-of-ldts/?ref=fdaweb.com) the agency safety warning told patients and healthcare providers about the potential of NIPTs to produce erroneous results, particularly false positives.

“Although FDA’s safety communication refers broadly to published literature and media reports supporting its assertions,” the blog post says, “it provides no specific evidence for these claims. Unfortunately, this is not the first time FDA has issued a safety alert regarding laboratory-developed tests (LDTs) without citing evidence of the alleged harm.”

The attorneys write that the agency appears to be making another attempt to gain express regulatory authority over LDTs. They note that the Senate HELP Committee recently released a discussion draft of the FDA Safety and Landmark Advancements Act of 2022 that would give FDA authority to regulate LDTs and fundamentally change the regulatory paradigm for all *in vitro* diagnostic tests.

“This recent development along with the lack of new evidence cited in the safety communication leaves us wondering about FDA’s true motivation for releasing it now,” the attorneys conclude. “If safety were the real driver, it seems to us there would be more recent and detailed information in the safety communication to give providers and patients about the true risks of these tests. If there are data to support the risks of these tests this information should be disclosed to providers and patients so that they make informed decisions. In the absence of such evidence, the safety communication raises alarm without context, conveying the impression that the product is unduly risky, and sowing doubt about the accuracy and reliability of LDTs more generally.”