Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MobiHealthNews, in “FDA Releases Revised Draft Guidance on CDS Software, Final Guidelines on ‘Device’ Definitions for Software Such as Wellness Apps,” by Dave Muoio.
Following is an excerpt:
The new guidances are intended to provide clarity on which products are or are not subject to regulatory enforcement, and to bring the agency’s efforts into compliance with provisions of the 21st Century Cures Act. …
Thompson initially described the guidance as a small, but important step forward for the agency, but still had some reservations in the FDA’s application of its risk-based approach. For starters, he wished that the agency did not limit its enforcement discretion to “software that provides information that merely informs clinical management of a non-serious disease or condition,” and instead included two other slightly higher risk subcategories suggested by his organization: “software that provides information to drive clinical management of a non-serious disease or condition” and “software that provides information that merely informs clinical management of a serious disease or condition.”
“The first of those especially is disappointing, because we are talking about nonserious diseases or conditions,” he wrote. “FDA wants to review CDS used to support recommendations to healthcare professionals on non-serious disease or conditions. It makes no sense to impose FDA regulatory obstacles on those categories of software.”
However, more alarming to Thompson was what he views as an ambiguous and “legally wrong” delineation between software intended “to guide” clinical management versus CDS tools that according to the document are “simply supporting or providing a recommendation about prevention, diagnosis or treatment of a disease or condition.” While the draft bases its distinction by referencing language in the 21st Century Cures Act, Thompson said that the definitions are far too similar intertwined to place into separate regulatory buckets.
"Essentially FDA is saying that ‘to guide’ clinical decision-making — which is the definition of ‘driving clinical management’ — is somehow fundamentally different than to ‘provide recommendations’ for clinical decision-making,” he wrote in a follow-up email. “That’s a distinction without substance. ‘Guiding’ clinical decision-making and ‘providing recommendations’ for clinical decision-making are the same. FDA is way in left field here, and they are trying to keep software companies from escaping FDA regulation by being transparent. This will not stand legal scrutiny. And in this sense, the new draft guidance is much worse than the old one.”
As a draft guidance, this CDS documentation will again be up for comment until December 26, 2019.