Regulatory Editor

The FDA's two-day workshop on the digital health pre-certification pilot was directed principally toward the agency's approach to certification of vendors rather than software products, but Zachary Rothstein of the Advanced Medical Technology Association said digital health products that will have to go through the PMA and 510(k) channels should enjoy a streamlined review process as well.

The FDA workshop provided feedback from participants in the digital health pre-cert program, which the agency launched in July 2017 in the anticipation that a company's demonstration of a commitment to quality would suffice to demonstrate safety and effectiveness in lieu of traditional premarket review mechanisms. The concept was part of the agency's action plan on digital health, although not all the agency's moves in this area have been well received, including the draft guidance for clinical decision support systems. (See BioWorld MedTech, March 1, 2018.)

Rothstein, who leads the digital health effort at AdvaMed, acknowledged that the pre-cert program could reduce the demands on FDA's resources and cut regulatory red tape for developers. He said, "We believe the pre-cert program should apply broadly" to include software as a medical device (SaMD) and software embedded in a medical device. Artificial intelligence should likewise be eligible for a pre-cert program in the future, Rothstein said, adding that any such programs "should be software- and platform-agnostic."

Program eligibility and certification criteria should be constructed such that developers of all sizes "have the same opportunities to participate," Rothstein said, adding that large firms with established key performance indicators and development practices "should be held to the same eligibility criteria as a small firm that may have fewer internal software development KPIs." In short, Rothstein said, "the playing field for eligibility must be level."

Rothstein said that the program "should right-size the premarket process so it is better aligned with software development practices," relying on the risks associated with that product type along with that developer's demonstrated excellence. He said software subject to review under the 510(k) program "should at a minimum be provided an exemption or a streamlined premarket review," while programs currently requiring a PMA should be "offered a streamlined premarket process" as well.

Patel notes program viability by end of 2018

Several FDA officials were on hand for the event, including Bakul Patel, the CDRH associate director for digital health. Patel said the pre-cert concept assumes that a review process, driven at least in part by feedback derived from real-world evidence sources, is still essential. Patel indicated that the FDA intends to expand the pre-cert pilot into a full-fledged program in short order. "We are hoping by the end of this year to get to a minimum viable program (MVP) that we can then move forward next year" out of the pilot stage and into a full-fledged program.

This MVP, Patel stated, will require that stakeholders come to agreement on several crucial points, starting with a more or less final version of an excellence appraisal model. Following this, stakeholders have to come up with a streamlined review approach, and subsequently, the best methods of real-world data access and analysis. Patel noted that each step will include a public feedback loop, adding that much of the effort up to now has revolved around development of a common vocabulary.

"We will get it right to some degree, we will get it wrong to some degree. The key point is that we need your help and input . . . to make sure we get it right," Patel said.

Jeff Shuren, director of the Center for Devices and Radiological Health, briefly addressed the gathering, stating that digital health technologies challenge the incremental changes to the device regulatory framework as originally spelled out in the 1976 Medical Device Amendments, largely because the software device is more rapidly iterative than a hardware device.

Shuren said simplicity is a priority for the agency's regulatory effort going forward, the pursuit of which requires that CDRH will be "continually streamlining" policies and programs. He said the 2011 mobile medical apps guidance was focused on functionality and agnostic about the platform, and said a "massive de-regulatory effort" accompanied the guidance.

Shuren said the agency will continue to emphasize the formation of collaborative communities in order to keep pace with technological change, vowing that such efforts will not revert to "collaboration on our terms." He pointed to a similar effort for development of standards for next-generation DNA sequencing systems, adding, "we think in moving forward . . . we should be establishing one or more of these collaborative communities" for many of the regulatory tasks that lay ahead. "Whatever we build, we will do this together," he concluded.

Data quality an issue

There are those who wonder how manageable large volumes of data are, but John Birch of the investment firm Mid-America Angels in Kansas City, Kan., said the quality of those data are less than ideal. Birch said, "We hear pitches from software entrepreneurs all the time," and he predicted "there's going to be a flood of software of all kinds" once the FDA digital health program matures.

Birch said the quality of data that is collected from sources external to a software device, such as the data fed into electronic health records, "is really lousy. Its inconsistent and it's dangerous," he said, citing a recent report that artificial intelligence will be stymied "until the data problem has been solved. Just a cascade of errors is going to result," he predicted.

"Patient registries are booming right now," Birch said, adding that predictions are that investment in patient registries will rise from about $300 million in 2017 to more than $2 billion in five years. He concluded remarks by asking, "Can registries be the solution to the data quality problem?"

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