- FDA is taking a second swing at defining how it plans to regulate clinical decision support software, releasing a revised draft guidance Thursday nearly two years after its controversial attempt at defining a regulatory framework in December 2017.
- The new draft guide appears to track with recommendations from the medical device industry that advocated a risk-based approach is needed for the software.
- The agency also separately released final guidance and revised four final guidances to clarify types of software, such as fitness apps, that are not defined as medical devices under the 21st Century Cures Act.
FDA Principal Deputy Commissioner Amy Abernethy said the slate of regulatory documents is aimed at adhering to the 21st Century Cures Act, while maintaining a balance between patient safety and promoting innovation.
"We've taken the goals we were entrusted with by Congress under the Cures Act and are building on these provisions to make sure that we're adopting the full spirit of the intent to provide a practical oversight framework that is risk based," Abernethy said.
The decision to revise the draft guidance comes after feedback on the 2017 version asked FDA to reconsider its approach, Bakul Patel, FDA director for digital health, told MedTech Dive. The new draft guide uses the International Medical Device Regulators Forum's risk-based framework for categorizing products, an effort to advance global regulatory harmonization.
"The feedback we got overwhelmingly was, 'how does it fit into the entire risk framework we've been talking about?'" Patel said. "I think that feedback was good. It's not about explaining the algorithmic thing, but it's explaining the basis of how you got to that."
Bradley Thompson, an attorney at Epstein Becker Green, said the new CDS draft guidance is a step forward, but does not go "nearly far enough." He argues FDA is taking too narrow a view of the IMDRF framework when choosing what types of software as a medical device are exempt from regulation.
FDA said it intends to focus its oversight on software that informs clinical management for serious conditions where a healthcare professional cannot independently evaluate the basis of software recommendations.
Still, the new draft guidance is a major overhaul that largely tracks with the risk-based approach the CDS Coalition asked for and is not just a tweaking of the original draft guidance, Greg Levine, an attorney at Ropes & Gray, told MedTech Dive.
FDA says it does not plan to enforce compliance for software functions that are intended to inform clinical management of non-serious conditions.
While software can still be regulated as a medical device in some cases, such as when information from a third device like an MRI or CT scan is used, if a software user understands the basis of the information and has time to consider it as part of an overall decision-making process, the software shouldn't be regulated as a device under the new guide, Thompson said.
The decision to rerelease the draft guidance for a 90-day public comment period adheres to a request by the CDS Coalition, an unexpected reversal, according to Thompson.
"Orally the agency flat out rejected our request," Thompson said in an email. "But times have apparently changed, and I am grateful to FDA for reconsidering its position. And the agency should be congratulated for keeping an open mind."
The new draft guidance largely abandons an effort to regulate patient decision support and clinical decision support as two separate categories.
"We got a lot of questions about the distinction between patient decision support and clinical decision support," Patel said. "What the new guidance basically says is that there is device CDS and non-device CDS. We tried to map the language in the statute to the vocabulary that was in the IMDRF risk categorization framework."
Thompson praised the move.
"In the new draft, FDA is taking a more general approach to such software saying that it will exempt from regulation that which is low risk, regardless of to whom it is directed," Thompson said. "That would presumably include software that is low risk by virtue of being transparent to patients, so long as patients can reasonably be expected to understand it. That's a good move."