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 Insight, in “US FDA’s Software Pre-Cert Program: Is the Authority on the Books?” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
Device and digital-health firms are looking toward US FDA’s imminent launch of the novel precertification program as an opportunity to streamline the path to market for new software. FDA has been regularly engaging stakeholders during the pilot stage with a goal to quickly get the first iteration of the program off the ground.
As part of the effort, the agency says it is carefully designing the program to fit within its current legal authorities. (Also see “Size Doesn’t Matter: US FDA Refines Dig-Health Pre-Cert Model” - Medtech Insight, 19 Jun, 2018.) But not everyone agrees it is meeting that standard. And, even if FDA can launch the program under current authorities, some say Congress may still look to have its say on the program next year.
In recent comments sent to FDA, the Clinical Decision Support Coalition, made up of health software developers, patient advocacy organizations, clinical societies, health-care providers and payers, argues that FDA can’t move forward with the ambitious pre-cert program unless Congress passes legislation to give it new regulatory authorities.
The agency has been working for almost two years on getting the pre-cert program going; it’s conducting a pilot project with the aim of launching the initial program by year’s end. However, attorney Bradley Thompson, chief counsel for the CDS Coalition, details the agency’s current statutory authority in the comments to FDA, and he argues that nowhere in those authorities is the agency granted powers for a pathway such as the pre-cert program.
“There may be some who think we are just being kill-joys in raising these issues. Some might say that the pre-cert program is wonderful, so why talk about all this legal stuff?” he states. However, he argues, these questions need to be asked to prevent legal hurdles in the future. …
But the CDS Coalition worries that FDA is wearing blinders, focusing solely on how to get the program up and running, rather than answering questions about its legality. While the group says it supports the pre-cert program, it is concerned about future legal ramifications if the pathway is eventually challenged.
“Where we may depart from the agency - and we don’t know the agency’s position other than the agency’s assertion that it can pursue a pilot program in 2019 without any legal authority - is that we think at the end of this process, FDA needs to go to Congress to get authorizing statutory authority, and then implement the program through authorizing regulations,” Thompson writes for CDS.
