Bradley Merrill Thompson Quoted in “CDRH Faces Tight Deadline as Questions Raised on Pre-Cert Pilot Design”

Regulatory Affairs Professionals Society (RAPS)

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Regulatory Affairs Professionals Society (RAPS), in “CDRH Faces Tight Deadline as Questions Raised on Pre-Cert Pilot Design,” by Ana Mulero.

Following is an excerpt:

As the US Food and Drug Administration (FDA) seeks to establish a new regulatory paradigm for digital health products by year’s end, the feedback received from a range of stakeholders on the proposed approach has continued to raise more questions than answers.

Officials at the FDA’s Center for Devices and Radiological (CDRH) have stressed the need for input on the creation of the new program—the Software Precertification Pilot Program—aimed at providing a fast track to the US market for participating digital health developers. …

The last comment period closed in June, with 11 submissions posted on the working model version 0.2. These include GE Healthcare and the Clinical Decision Support Coalition (CDS), which expressed concerns over regulatory burden and FDA staffing challenges.

CDS general counsel Bradley Merrill Thompson also raised doubts about the benefits to companies with low-risk products.

“For those products that are ultra-low risk, the calculus is even more tilted toward staying out of the precert program,” Thompson wrote. “For those companies, the Pre-Cert program offers nothing, so the burdens of the program entirely outweigh the benefits.”