EBG Commentary

Bradley Merrill Thompson Quoted in “CDS Coalition Releases Guidelines in Self-Regulatory Effort”

FDA Week

Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in FDA Week, in “CDS Coalition Releases Guidelines in Self-Regulatory Effort,” by David Lim.

Following is an excerpt:

The 21st Century Cures Act puts certain CDS software outside the scope of FDA regulation. “While FDA will need to interpret the exact line drawn by the statute, the CDS Coalition wants to give FDA confidence that when it comes to software the agency does not regulate, industry will do an adequate job of self-regulation,” wrote Brad Thompson, general counsel for the CDS Coalition. The Cures law provides an avenue for FDA to clawback into regulated territory any software the agency finds may lead to serious injury or death in patients. “If industry does an adequate job of self-regulating and therefore avoiding patient injury, we can reduce the likelihood that FDA will need to expand the scope of its regulation,” Thompson said. …

“[T]hese guidelines are intended to bring a focus to the developer’s thought process regarding the issue of whether the developer wants to take the steps necessary to ensure the user remains fully in control, or whether the software developer decides that it’s better to take over some of the decision-making and correspondingly increase the level of validation the software needs,” Thompson wrote.