A new FDA document appears to significantly expand the agency’s oversight of software that helps clinicians make decisions about patients’ treatment - a departure from a 2019 draft guidance that an industry legal expert on medical software described as alarming and said might require congressional intervention.
In the guidance, published Tuesday (Sept. 27), FDA says it will consider software that gives providers specific recommendations about the treatment of patients to be a medical device, as well as software that includes more medical information about a patient than what could be disclosed in a conversation. …
Bradley Merrill Thompson, member of law firm Epstein, Becker & Green and general counsel for the CDS Coalition, said he was “somewhat appalled” by how different the criteria in the new guidance are from both the language in the Cures Act and in FDA’s 2019 draft guidance on the issue.
Thompson said the FDA’s policy distinguishes what is and is not a medical device purely on the basis of how confident the program’s language recommending a treatment approach is. While the Cures Act sought to limit FDA oversight of CDS software, he said, the new guidance seeks to reassert that authority over many manufacturers of software not previously considered medical devices.
“They’re going to be caught completely off guard, and it’s going to sweep into FDA a very large number of products that previously we thought were exempt,” he said. …
Thompson said he was also taken aback by the narrowness of the medical information that can be included in non-device CDS software under the new guidance. The legislation on the topic specifies only that patients’ medical information can be included.
“That in no way limits it to information that would be understandable by the patient,” he said, much less information that would be shared in a typical doctor-patient conversation.
Because the new guidance is such a departure from the 2019 draft, Thompson said, FDA should have treated it as a new draft rather than a final guidance and allowed for a public comment period. Since it did not, he said, the likely only recourse for software companies will be to appeal to Congress to clarify what it meant in the Cures Act and specifically limit FDA’s authority.