Software developers who were hoping that the Food and Drug Administration’s Center for Devices and Radiological Health might issue draft guidance on clinical decision support (CDS) software have once again been disappointed.

According to the FDA, its Center for Devices and Radiological Health (CDRH) is considering developing a variety of guidance in fiscal year 2017, including its so-called “A-List” documents, those that the agency intends to publish between Oct. 1, 2016 and Sept. 30, 2017. However, draft CDS guidance is not among CDRH’s priorities going into next year.

Among those disappointed that CDS is not on the agency’s near-term agenda is Bradley Merrill Thompson, general counsel for the Clinical Decision Support Coalition, which represents software developers, healthcare payers, providers and medical device manufacturers.

“For the last two years, CDRH has placed in the category A priority list draft guidance on clinical decision support software. It isn't on the list this year, despite the fact that CDRH has not published the draft guidance,” says Thompson.

Thompson contends that industry has been waiting for FDA guidance on CDS since 2011. When it comes to software development, five years is an eternity, he contends.

Bradley Merrill Thompson
Bradley Merrill Thompson

Without clarification on how the FDA plans to regulate CDS, the software category will remain a gray area, leaving developers struggling to get funding and to put together business plans that accurately reflect the expected regulatory path for their products, Thompson argues.

Survey results released earlier this year by the CDS Coalition showed that one-third of developers reported having to abandon CDS product development efforts because of uncertainty over FDA regulations. Of those who pressed ahead despite the uncertainty, almost two-thirds encountered significant delays.

In a written statement, an FDA spokesperson said the agency is “carefully evaluating” the 21st Century Cures Act that was passed by Congress and signed into law earlier this month by President Obama, and it is “exploring all possible options for implementing the responsibilities, including the provision for clinical decision software, that we’ve been charged with under the new law.”

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

Thompson believes the FDA removed CDS from CDRH’s FY17 list of guidance documents because the agency plans to re-evaluate the need for CDS guidance in connection with implementing the 21st Century Cures Act.

“That legislation, in section 3060, adds the criterion that to be FDA regulated, CDS software must not be transparent. In this context, transparent means that the doctor user cannot see through the software to the underlying patient data and the clinical logic applied by the software, such that the physician is not required to rely on the software,” says Thompson. “My hope is that in connection with the legislation, FDA proceeds with the guidance, which is more important now than ever before.”

Specifically, the CDS Coalition would like to understand how the agency plans to enforce the transparency concept. “The statute is very helpful, but it will be very important for FDA to express the agency’s views on how the language is to be interpreted and applied,” adds Thompson.

“I will be very anxious to see the FDA’s plans for implementing the Cures legislation,” he concludes. “I certainly hope that they plan to proceed with this much needed guidance.”

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