This morning, the United States Food and Drug Administration (FDA) released new guidance to provide greater clarity in the regulation and adoption of medical-grade software and digital health innovations. Under the direction of the 21st Century Cures Act, the three new pieces of guidance target the role and regulation of software, dependent on their specific use and beneficiaries. Morgan Reed, executive director of ACT | The App Association’s Connected Health Initiative, released the following statement in response to the FDA’s announcement.
“Today, the FDA finally released guidance on clinical decision support software. This long sought-after guidance is an important first step, and recognizes the many ways software can help physicians make meaningful decisions about patients’ health and treatment options. We look forward to analyzing the specifics in the guidance, and seeing how we can better support our members in developing live-saving software.
“For years, our members have developed clinical and patient decision support software, but their solutions will not be adopted, nor their benefits felt, absent a clear regulatory framework. Today’s guidance focuses regulatory intent on the safety and effectiveness of software that independently analyzes patient data, rather than on software that supports doctors’ ability to use data to make treatment decisions. We certainly expect new questions to arise as innovative software is introduced, but this marks an important beginning in recognizing the utility of decision support software as a supplemental tool in the continuum of care.”
On the FDA’s changes to Mobile Medical Applications (MMA) guidance, Reed noted:
“We have long been strong supporters of the FDA’s risk pyramid framework that was part of the September 2013 MMA guidance. We are pleased to see the FDA move additional categories of applications into the “unregulated” space as they pose no significant patient risk. In light of the increasing number of health and wellness products, the FDA’s decision to reduce regulation will support greater innovation and impact.
“In the year ahead, we look forward to participating in Pre-Certification Pilot workshop as part of the Digital Health Innovation Action Plan. This dialogue is a vital opportunity to inform FDA regulators and staff about new changes in software development models to help create a more iterative and reactive regulatory process—to the benefit of doctors, patients, and innovators alike.”
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