Most of the provisions in the 21st Century Cures Act clarifying medical software regulation are straightforward and welcomed by industry, but it is unclear how the FDA will apply a provision on clinical decision support software.

Section 3060 of the Act exempts five categories of software from regulation as a medical device, including software used for administrative support, maintaining or encouraging a healthy lifestyle, electronic patient records, processing or displaying clinical data or related findings by a healthcare professional, and supporting or providing treatment recommendations.

The software exclusions “are welcome news to an industry that has been struggling with the question of whether its products are subject to FDA regulation,” attorney Jeffrey Shapiro at Hyman, Phelps & McNamara said.

However, Shapiro said it remains uncertain how the FDA will apply the exclusion of software used for clinical decision support software (CDSS), which supports or provides recommendations regarding treatment decisions. Specifically, the provision excludes software that:

• Displays, analyzes, or prints medical information;
• Supports or provides recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and
• Enables the health care professional to independently review the basis for — rather than rely primarily on — the software’s recommendations when making diagnostic and treatment decisions.

The FDA has considered issuing CDSS guidance for the past few years. Although the exemption removes the need for guidance, it presents unresolved questions for manufacturers.

In particular, it is unclear what it means for a health care professional to “independently review” the basis for recommendations by software as opposed to “relying on” the software to make a decision — an issue that is ripe for future FDA guidance. Shapiro said that the relevant distinction arguably should be whether the basis of the software’s recommendation is clear, and thus can be intelligently accepted or rejected similar to when talking with a colleague, or whether the health care professional blindly relies on the software’s recommendations without knowing how they were reached.

A particular healthcare professional’s training and expertise plays a role, because a primary benefit of CDSS is to encapsulate the expertise of the best-trained and most experienced doctors for the benefit of others who might rely more heavily on the software’s recommendations. As a result, the FDA might make distinctions among health care professionals for whom the CDSS is intended when determining if it is regulated as a medical device.

By contrast, Shapiro said three of the excluded software categories are unsurprising and should not be controversial. Administrative support software such as Microsoft Word “is obviously not a medical device,” he said. In addition, the FDA previously indicated it would not regulate lifestyle and patient record software even if it fell under the definition of a medical device. The Act simply clarifies that it does not.

Shapiro said the fourth category — software that processes or displays clinical data or related findings by a healthcare professional — appears to include products meeting the definition of either a medical device data system (MDDS) or a laboratory information system (LIS).

The FDA has previously announced it is exercising enforcement discretion not to regulate MDDS, and Section 3060 codifies that position. The agency currently regulates LIS as 510(k)-exempt Class I devices that are intended to store, retrieve, and process laboratory data. The FDA has continued to apply the quality system regulation to these devices, but under this exclusion, LIS products are no longer subject to the QSR or any other regulatory requirements.

Provision Offers Accountability

The provision on breakthrough devices in the 21st Century Cures Act will bring needed clarity for manufacturers and accountability for the FDA, according to one prominent regulatory consultant.

Section 3051 requires a new FDA program offering priority review of devices that provide more effective treatment or diagnosis of life threatening or irreversibly debilitating human disease or conditions. The program would also deal with breakthrough technologies for which there are no approved alternatives, or that offer significant advantages over existing alternatives.

In the past, FDA decisions regarding which devices are innovative enough to warrant expedited approval have not been based on formal, well-understood criteria, and therefore may be “well-intentioned,” but could be somewhat “arbitrary and inconsistent,” according to Compliance Architects Founder Jack Garvey. By establishing formal criteria for a breakthrough device, Section 3051 will offer more certainty for manufacturers and make the FDA more accountable. “I don’t think it will create more of a burden on industry, but it will force the FDA to up their game a little bit in terms of the rigor of their decisions,” he said.

University of Cincinnati Professor Jim O’Reilly said although there are good rationales for the breakthrough device program, there is a chance that consumers could be hurt if devices are approved too quickly or with insufficient data. If that happens, the FDA will be able to use Section 3051 to justify its decision.

“Historically, we’ve driven our regulatory controls by a sense of fear that if we make a wrong decision, it will harm consumers,” he said. As a result, the FDA has “tried to avoid risk at all costs” and required more and more data before approving medical devices. However, with the passage of the 21st Century Cures Act, “inaction is not going to be held against the FDA reviewers, and someday I suspect Congress will be held responsible for devices that cause harm,” O’Reilly said.

Another unresolved issue stems from the fact that Section 3051 opens priority review to device types subject to 510(k) clearances and not just PMA approval or de novo requests. Jay Crowley, vice president of UDI Services and Solutions at USDM Life Sciences, questioned the usefulness of this provision.

“A 510K device by definition is substantially equivalent to a currently marketed device, so it’s a little hard to understand how you could have a novel device that is also a 510(k) product,” he said. “When you think about unmet needs, you typically think about new products.”

However, he agreed that the expedited pathway for breakthrough devices is helpful overall. “Everyone has to agree — which is a bit of a challenge — that a device meets an unmet need, but it’s a useful tool from a social perspective,” Crowley said. “It allows the FDA to do the right thing when the right thing is put before them.”

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