Companies participating in the US Food and Drug Administration's (FDA) pilot software pre-certification program reflected on their experiences in the earliest stages of the pilot at a public workshop in Bethesda, MD on Tuesday.

Background

Last year, FDA launched its "Pre-Cert" pilot program for software-based medical devices as part of its Digital Health Innovation Action Plan.

In September, the agency selected nine companies to participate in the pilot: Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily.

Since then, FDA has gone on a series of two-day site visits to each of the participants to identify traits and practices at each of the companies that could contribute to organizational excellence and software quality and how those approaches could integrated into a model for pre-certifying a company's products.

Ahead of the workshop, FDA also updated its questions and answers page on the Pre-Cert pilot and released an overview of its first steps and proposed excellence model for validating company's software development practices.

Early Experience

Kicking off the two-day workshop, Center for Devices and Radiological Health (CDRH) Director Jeffery Shuren said the goal of the pilot is to figure out how to build a regulatory pathway for digital health products that will encourage companies to come forward with innovative new products.

"We want this program to be scalable, we want this program to be easy, we want this program to align as closely as possible to how businesses run and make products," said Bakul Patel, associate center director for digital health at CDRH.

By and large the participants in the pilot applauded FDA's efforts and approach, and agreed that the agency's existing review pathways are not well-suited to software-based products.

"The decades old regulatory paradigm just did not contemplate the challenges that we see with the rapid innovation and iterative nature of software, so the precertification pilot for us was the first step in trying to find a more fit-for-purpose regulatory paradigm," said Danelle Miller, vice president of global regulatory policy at Roche.

Jennifer Newberger, senior legal counsel at Apple echoed that thought, saying "there really is a genuine interest here in creating something that is specific to the situation. It isn't taking what already exists and tweaking it slightly to make it work for software, it's really trying to create something new for software and the pace at which software develops."

Both Miller and Newberger also said that it's hard to separate out some of the existing regulatory requirements for medical devices, such as establishing a quality system or maintaining a design history file, but said that an approach focused on organizational excellence could yield quality digital health products.

After taking part in her company's site visit, Diane Johnson, digital health policy lead at Johnson & Johnson, said the one lingering question she had was how FDA will approach enforcement for pre-certified companies.

But Patel replied that FDA still does not have a precise idea about the level of enforcement that will be required to oversee pre-certified products or the specific metrics they will be looking at.

FDA