Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in RAPS Regulatory Focus, in “Legal Expert: FDA’s CDS Software Guidance Is a ‘Disaster’ for Industry,” by Ferdous Al-Faruque.

Following is an excerpt:

The US Food and Drug Administration’s (FDA) final guidance on clinical decision support (CDS) software goes against the statutory language laid out in the 21st Century Cures Act, according to a legal expert following the matter. While the guidance seeks to elaborate what CDS software FDA will regulate, critics said the agency’s rationale goes against what Congress has mandated.
The Cures Act included language stating that the FDA should not regulate certain medical software such as CDS software, so long as it is not the primary decision resource for health care providers (HCP). Such unregulated software should also allow physicians to independently review the basis for the medical decision.
On 27 September, the FDA published a final guidance titled Clinical Support Software, that Bradley Merrill Thompson, attorney at Epstein Becker Green, says overrides Congress’ mandate and broadly expands the agency’s oversight authority.
“FDA clearly wants to block what Congress has done, to the point where it is reaching nonsensical conclusions about what statutory language means,” he told Focus.
Thompson said that FDA’s decision to narrow what CDS software it won’t regulate was in response to comments it received on its 2019 draft guidance, in which stakeholders argued that the agency’s risk-based framework for deciding which software to regulate violated the Cures Act. …

“Having realized that the agency couldn’t defend its interpretation in that regard, the agency shifted approaches and came up with this entirely new attack on the statute and then went right to final guidance with it,” said Thompson. “Never have I seen in 35 years of practicing food and drug law a guidance document so radically changed from proposed to final as this one.”
Thompson said that FDA seems to be “desperately trying to draw a distinction” between software that asserts diagnoses versus those that are more nuanced in their diagnostic recommendation. He also noted that the agency has removed a section on risk that was based on discussions with the International Medical Device Regulators Forum (IMDRF). 

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