FDA not planning to establish guidance on CDS in 2017

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who were expecting that the Food and Drug Administration’s Center for Devices and Radiological Health might release draft guidance on clinical decision support (CDS) software have once again been disappointed.

In accordance to the FDA, its Center for Devices and Radiological Health (CDRH) is considering establishing a variety of guidance in fiscal year 2017, involving its so-called “A-List” documents, those that the organization intends to publish between the time period of Oct. 1, 2016 and Sept. 30, 2017. Although, draft CDS guidance isn’t among CDRH’s priorities going into next year.

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

“For the last 2 years, CDRH has placed in the category A priority list draft guidance on clinical decision support software. It is not on the list this year, despite the fact that CDRH hasn’t released the draft guidance,” says Thompson.

Thompson asserts that industry has been waiting for FDA guidance on CDS since the year of 2011. When it comes to software development, 5 years is an eternity, he asserts.

Without clarification on how the FDA plans to regulate CDS, the software category will sustain to be a gray area, leaving developers struggling to get funding and to put together business plans that precisely depict the expected regulatory path for their products, Thompson explains.

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

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

Thompson considers the FDA removed CDS from CDRH’s FY17 list of guidance documents because the agency plans to re-evaluate the requirement 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, Clinical Decision Support (CDS) software must not be transparent. In this context, transparent means that the doctor user can’t see through the software to the underlying sufferer data and the clinical logic applied by the software, such that the physician isn’t required to rely on the software,” claims Thompson. “My hope is that in connection with the legislation, FDA proceeds with the guidance, which is more significant now than ever before.”

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

“I’ll be very anxious to see the FDA’s plans for implementing the Cures legislation,” he summarizes. “I certainly expect that they plan to proceed with this much required guidance.”