FDA Commissioner Dr. Scott Gottlieb has been saying all the right things regarding digital health. But if we look beyond blog posts and press releases, the agency’s performance has been underwhelming. 

The agency is working on a precertification program that will focus on vendors rather than products. Much like the TSA pre-check program, if the FDA does an adequate job of vetting software developers up front, they can allow an expedited path to market with new software products. The FDA is piloting the program and was scheduled to host a public meeting January 30.  

Program participants must understand that, like the TSA pre-check program, the government will have to get much more intrusive in reviewing their operations.  

See also: The FDA issues its second enforcement letter of 2017

The FDA apparently wants to do a full body cavity search of these businesses, exploring over 100 topics, including whether a company has a formal program to encourage a proactive corporate culture. 

Perhaps the biggest disappointment was the FDA’s December 2017 draft guidance on clinical decision support software.  

After having repeatedly promised Congress and the public its program would be risk-based, the agency came out with guidance that did nothing more than follow the 21st Century Cures Act provisions exempting transparent software from FDA regulation and extending those provisions to patient-directed software.  

See also: The FDA cites risk info in letter over Contrave DTC ad

The agency completely ignored its own work in connection with the International Medical Device Regulators Forum, which specifically identified risk factors that allow tailoring regulatory requirements to the risk level of the software. 

We will have to wait to see how the FDA crafts the precertification program and finalizes the clinical decision support guidance, but I am getting cynical the new FDA is actually much like the old one.



Bradley Merrill Thompson is an attorney with the law firm Epstein Becker & Green.

From the February 01, 2018 Issue of MM+M - Medical Marketing and Media