The Food and Drug Administration is creating a digital health unit within its Center for Devices and Radiological Health in an effort to develop internal technical expertise, and streamline the agency’s software review process and regulation of medical devices.

“Because it’s such an emerging area, having a centralized unit in the Center Director’s Office is important for coordination on digital health topics and having consistency in applying policies,” says Bakul Patel, associate director of digital health in the FDA’s CDRH.

Bakul Patel

Among its responsibilities, the digital health unit will work on:

  • Developing software and digital health technical expertise to provide assistance for premarket submissions that include Software as a Medical Device (SaMD), software inside of medical devices (SiMD), interoperable devices or otherwise incorporate novel digital health technologies.
  • Utilizing technical experts as appropriate or when requested by the manufacturer for submissions that include SaMD, SiMD, interoperable devices or otherwise incorporate novel digital health technologies.
  • Incorporating appropriate metrics for digital health improvements to monitor, track, analyze and report the results of digital health premarket review timelines.

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The digital health unit will be established in the CDRH’s Office of the Center Director as part of the next iteration of the Medical Device User Fee Amendments, under which the FDA is authorized to collect user fees from medical device manufacturers. In exchange for those fees, FDA commits to meeting certain performance goals, such as reviewing submissions within specified timeframes.

The medical device users fees, which must be reauthorized every five years, expire in September. The next iteration of the agreement, negotiated between FDA and the medical device industry, requires congressional authorization for fiscal years 2018 to 2022.

“The funding starts on Oct. 1, 2017, the next fiscal year,” says Patel, who notes that existing FDA staff will not be reassigned to the new digital health unit. Instead, the agency will hire technical experts in various fields from the private sector—a total of 13 full-time equivalent (FTE) positions.

“The world of digital health has a lot of expertise that we need to supplement our organization with,” Patel adds. “If we had to do it all internally, then it would defeat the purpose.”

According to an FDA spokesperson, the new full-time employee allocation “will be something we plan to work on through this year in hopes of having them onboard next fiscal year.”

Bradley Merrill Thompson, an attorney at Washington-based law firm of Epstein Becker Green who counsels medical device companies on regulatory issues, says that industry has long supported medical device users fees and the concept of an FDA digital health unit.

“On the whole, industry has been hoping that FDA would create this office for years, and indeed it was a specific recommendation of the FDASIA working group a few years ago, so it is great that it will finally come to be,” Thompson notes.

At the same time, he warns that the problem for the agency will be recruiting staff for the digital health unit. “Right now salaries for people in those domains are sky-high, and that means many folks are very nervous about how FDA will succeed in recruiting the talent it needs,” adds Thompson. “For example, machine learning is a key knowledge base that FDA should have going forward, but machine learning people are in extremely scarce supply.”

Patel acknowledges that the agency’s effort to recruit staff for the digital health unit, particularly finding people with expertise in artificial intelligence, cloud computing, cybersecurity and interoperability. However, he says he believes that the mission and purpose of the FDA is a big selling point for potential candidates.

“Healthcare can really benefit from us being nimble, as well as proactive and pragmatic in how we apply policies in these emerging areas—and, for that we need people who understand these emerging areas,” Patel concludes. “The task in front of me is to get the right people on board.”

Nonetheless, Thompson fears that even if the FDA is able to successfully recruit staff for the digital health unit, the agency will have difficulty retaining such people.

“There may be folks who come right out of school who feel like this would be a good career opportunity for them. And that's great, until they leave,” he says. “But that's the market. They become very marketable because people want folks with technical expertise and an understanding of the FDA processes.”

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