FDA looks to De Novo pathway model as it unveils updates to Pre-Cert program

FDA Comissioner Dr. Scott Gottlieb announced a new Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model.
By Laura Lovett
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  (Photo by Drew Angerer/Getty Images)

The FDA unveiled new updates on the ongoing Pre-Cert program including a Digital Health Innovation Action Plan, Pre-Cert Test Plan for 2019 and a Working Model. 

One of the big take aways from yesterday's announcement is that the FDA is looking to use the De Novo model to implement the next phase of the Pre-Cert pilot. The second is that the organization plans on setting up a parallel submission review process that compares the streamlined De Novo Pathway to the traditional submission pathway. 

The Pre-Cert program has been in the works for about a year and a half. The idea for the Pre-Cert program was first introduced in August of 2017, which proposes to allow certain companies that the FDA has deemed responsible and safe in their development to build products without each new device undergoing the FDA clearance or approval process. This was followed by the launch of a pilot program, where nine companies of various sizes began developing programs using this pathway.

In a statement released yesterday, FDA Commissioner Dr. Scott Gottlieb explains the reasoning behind looking to the De Novo pathways for this program. 

“We believe the most efficient way to test this type of program is to do so within the FDA’s current regulatory authorities,” Gottlieb wrote. “Today, we’re releasing our outline, titled Regulatory Framework for Conducting the Pilot Program within Current Authorities, to describe how the agency intends to use our De Novo pathway for novel technologies to implement the next phase of the Pre-Cert pilot. … Our De Novo pathway is well-suited to meet the goals of our Pre-Cert program because it is a pathway for certain novel types of low- to moderate-risk devices to obtain marketing authorization.”

Gottlieb goes on to describe how in the current De Novo pathway companies are required to meet Quality System Regulations (QRS) to demonstrate design control and validation. 

“In the Pre-Cert model, many of these QSR requirements would be satisfied by information the FDA collected through the Excellence Appraisal process, which is aimed at evaluating the quality and excellence of the software developer for Pre-Cert. By collecting this information early, the Excellence Appraisal could be leveraged to streamline a developer’s De Novo submission, reducing content the developer would need to submit to the agency under the De Novo pathway since the information would already have been demonstrated and documented during the Excellence Appraisal.”

The FDA also released the Pre-Cert Test Plan for 2019, which includes running two different tests on the same device. 

“We want to test how the Pre-Cert approach utilizing the streamlined De Novo pathway compares to our traditional submission pathway,” Gottlieb wrote. “To do so, we will review the sponsor’s traditional De Novo submission for its device and using that same submission information we will, in parallel, review the sponsor’s Excellence Appraisal information with the proposed streamlined submission content.”

But since FDA released the new documents yesterday industry players have had mixed reviews. 

Bradley Merrill Thompson, a partner at Epstein Becker Green who specializes in consulting with digital health startups about FDA clearance, took issue with the new De Novo component of the Pre-Cert proposal. 

“It’s in those two documents that FDA really fleshes out the idea that initially, only software as a medical device that would qualify for a de novo submission will be included in this pilot program,” Thompson wrote in an email to MobiHealthNews. “As you undoubtedly know, the de novo process is restricted for devices that are unlike any that have ever come before. Hence the name de novo. More specifically, it is for devices for which there is no existing classification. They are unprecedented.”

He goes on to discuss the limitations that the De Novo could have on the industry. 

“FDA has been selling this precert program as the best thing since sliced bread for essentially all software as a medical device. Now they’re saying that at least initially it will be restricted to unprecedented software. In 2018, there were roughly 30 De Novo requests granted. I haven’t seen exact numbers, but there are typically about 3000 510 K’s per year. This means that the precertification program would be limited to that 1 percent of medical devices that are unprecedented. That is a very small slice, and will therefore be of limited interest to the software industry.”

But others see this latest announcement as a concrete move forward with the plan.  

“Commissioner Gottlieb’s announcement today regarding new actions for the Digital Health Precertification (Pre-Cert) Program is a welcomed move toward giving teeth to the program originally announced in the July 2017 Digital Health Innovation Action Plan,” Kyle Faget, a special council and business lawyer with Foley & Lardner, wrote to MobiHealthNews. “Having a clear regulatory framework for testing new approaches for the review of digital health device applications, engaging in a test plan to asses how the program can maintain standards for assuring safe and effective products, and releasing a working model that incorporates the regulatory framework and the test plan aimed at establishing the components FDA envisions for the future of Pre-Certification program is evidence that the FDA is committed to supporting the efficient review and ultimate commercialization of digital technologies.”