Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in MedTech Dive, in “FDA Revises Clinical Decision Support Software Draft After Industry Blowback,” by David Lim.
Following is an excerpt:
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. …
Bradley Thompson, an attorney at Epstein Becker Green, said the new CDS draft guidance is a step forward, but does not go “nearly far enough.”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. …
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The decision to rerelease the draft guidance for a 90-day public comment period adheres to a request by the CDS Coalition, an unexpected reversal, according to Thompson.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The new draft guidance largely abandons an effort to regulate patient decision support and clinical decision support as two separate categories.
