Capitol Correspondence - 09.29.20

Big Picture: FDA Announces Center to Advance Medical Tech Outside of Traditional Health Care Settings

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People with disabilities are key stakeholders in improving medical devices and other medical technology, as many of those products are not accessible – either because of their design or because doctors’ offices might be physically inaccessible. To keep our members informed of broader policy discussions that could help address this issue, we are sharing reporting by Politico Pro on a new Food and Drug Administration initiative.

“The FDA announced Tuesday the launch of its new digital health center of excellence, a step Commissioner Stephen Hahn says will help advance medical technology outside of traditional health care settings.

Bakul Patel, FDA’s director of digital health, will oversee the center within the Center for Devices and Radiological Health. He said the launch reflects the exponential growth of the digital health field in recent years. The idea is to provide a central repository for the public, industry and FDA to discuss digital health policy and regulation.

‘It creates a platform for people to have an aligned conversation,’ Patel told POLITICO. ‘It allows not only alignment with CDRH, but it also helps other centers within FDA to avail the expertise and experience we have gained.’

FDA says immediate priorities will include research into digital health regulatory science to help advance oversight of devices. Patel said FDA will continue to issue regulatory documents to support the digital health field even if it means getting additional clearance. The White House has been reviewing any regulatory guidance it deems noteworthy.

‘We will continue to do what we have been doing,’ Patel said. ‘Obviously, we have to make sure that the documents go out with the right level of eyes on it.’

Background: FDA released its Digital Health Innovation Action Plan in 2017. It outlined plans to develop guidance to implement the medical software provisions of the 21st Century Cures Act and to launch the agency’s digital health precertification program pilot. The pilot is exploring if FDA can allow device makes to develop and patch software by pre-clearing certain companies instead of reviewing each iteration of a device’s software.

The agency proposed in its fiscal 2019 budget request the creation of a digital health center of excellence. At the time, the FDA said the center would include a new cybersecurity unit to help aid review of medical hardware and software.

What’s next: FDA is holding two virtual listening sessions to gather input on the digital health center on Oct. 19 and Nov. 12.

The next round of Medical Device User Fee Amendments negotiations also will kick off soon. FDA is holding its first MDUFA V virtual public meeting on Oct. 27.”