The Food and Drug Administration has issued draft guidance on clinical decision support software for healthcare providers to clarify what types of systems will no longer be defined as medical devices and therefore will not be regulated by the agency, based on provisions of the 21st Century Cures Act.

Under the Cures Act signed into law late last year, certain CDS software is now outside the scope of FDA regulation.

“CDS that allows for the provider to independently review the basis for the recommendations are excluded from the FDA’s regulation,” said FDA Commissioner Scott Gottlieb, MD, in a statement. “This type of CDS can include software that suggests a provider order liver function tests before starting statin medication, consistent with clinical guidelines and approved drug labeling.”

Nonetheless, Gottlieb pointed out that the regulatory agency will “continue to enforce oversight of software programs that are intended to process or analyze medical images, signals from in vitro diagnostic devices or patterns acquired from a processor like an electrocardiogram that use analytical functionalities to make treatment recommendations, as these remain medical devices under the Cures Act.”

Also See: 21st Century Cures Act clarifies FDA regulation of software

The draft guidance also attempts to make clear the scope of FDA’s regulatory oversight of patient decision support (PDS) software intended for patients and caregivers.

When it comes to patient decision support, the FDA proposes to not enforce regulatory requirements for lower-risk decision support software that enables a patient or a caregiver to independently review the basis of treatment recommendation.

“Although PDS was not part of the Cures Act, the FDA believes that PDS should follow a similar regulatory structure as CDS,” said Gottlieb. “An example of lower-risk PDS products could include software that reminds a patient how or when to take a prescribed drug, consistent with the drug’s labeling.” However, he added that “PDS software that does not clearly allow independent review of the recommendation by the patient or a caregiver would continue to be subject to the FDA’s active oversight.”

“We believe our proposals for regulating CDS and PDS not only fulfill the provisions of the Cures Act, but also strike the right balance between ensuring patient safety and promoting innovation,” added Gottlieb.

However, Bradley Merrill Thompson, an attorney at Washington, DC-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, says overall he is disappointed in the FDA’s draft guidance, especially as it relates to CDS.

“The problem is that FDA seems to have walked away from making a risk-based determination,” says Thompson. “What I think many of us in industry were hoping for was an effort by FDA to distinguish high from low risk as a basis for regulation. We didn’t get that. Worse, it appears based on the guidance that FDA is not interested in drawing that line.

“The FDA guidance seems to be fine for historical software that simply takes existing clinical guidelines and applies them formulaically to patient data,” he adds. “Companies have been doing that for decades without FDA oversight, and FDA is now recognizing that so long as the software strictly follows the guidelines and the guidelines are available, such software should not be regulated. But the future of CDS software is in machine learning and other forms of complex algorithms that add to the knowledge of physicians. And FDA seems to be saying that all such software will be regulated regardless of risk. That’s extremely troublesome.”

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