FDA launches years-in-the-making digital health center

By | September 24, 2020

Dive Brief:

  • FDA on Tuesday announced the creation of a digital health center within the Center for Devices and Radiological Health where it will coordinate policy and regulatory approaches tailored for the technologies. Bakul Patel, who has led the agency’s digital health regulatory and scientific efforts for the past decade, was named the center’s first director.
  • Dubbed the Digital Health Center of Excellence, its establishment builds on several years of effort at FDA to advance the agency’s regulatory approach in the fast-growing digital arena, for example through the software pre-certification pilot program that is continuing through 2020.
  • FDA said many aspects of the center are still under development. The agency plans to explain the purpose and functions of the center and collect feedback from digital health device manufacturers, developers, healthcare providers, researchers and others during webinars scheduled for Oct. 19 and Nov. 12.

Dive Insight:

The center’s primary aim will be to ensure the rapid development and review of digital health technologies, FDA Commissioner Stephen Hahn said. Focus areas of the initiative will include cybersecurity, the Pre-Cert program, artificial intelligence and machine learning in software as a medical device (SaMD), along with mobile health devices, wearables when used as a medical device and technologies used to study medical products.

A digital health center at FDA was initially proposed in President Donald Trump’s budget request in 2018 and was touted as a top priority when former Commissioner Scott Gottlieb still led the agency.

The center’s launch “is part of the planned evolution of the FDA’s digital health program to amplify the digital health work that is already being done and building upon years of work at the agency,” CDRH Director Jeff Shuren said in a statement. “In the last several years, we have established partnerships internally and externally to coordinate digital health activities and to promote the consistency of regulatory policy while continuing to innovate in our regulatory approaches.”

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Among its functions, the center will provide technological advice, support work being done across FDA, promote best practices and develop digital health device oversight. The center also will create a network of experts to share knowledge and experience on digital health issues and priorities with FDA staff, and will facilitate regulatory science research in digital health.

The center’s unveiling comes a week after FDA provided an update on its Pre-Cert pilot launched in 2019 that involves Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. Evaluation is ongoing for the Pre-Cert program, which aims to accelerate development of software-based medical device products by reducing certification hurdles. The agency said it will consider obtaining legislative authority to implement it as a new regulatory pathway for SaMD.

FDA also continues its work toward a regulatory framework to support AI and machine learning algorithm changes to SaMD based on real-world learning and adaptation. Speaking earlier this month, Patel said the agency’s next step in this area will be a series of documents following up on its April 2019 discussion paper. FDA is looking to industry for input on machine learning practices, he said.

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