FDA to create digital health unit

The Food and Drug Administration (FDA) is developing a unit focused on digital health within its Centre for Devices and Radiological Health (CDRH) to assist the organisation’s review process of software within the medical device sector.

The digital health unit will be responsible for developing software and technical expertise which can provide assistance to software and devices that incorporate digital health technologies and assessing digital health improvements and monitoring and reporting on the digital health premarket review timelines.

The unit will be based in the CDRH’s Office of the Centre Director under the next iteration of the Medical Device Users Fee Amendments.

The FDA is currently working on a validation process for software according to the organisation’s associate centre director for digital health, Bakul Patel.

Speaking at MedCon in Cincinnati Bakul said that the FDA is currently looking at over 1,000 comments relating to draft guidance on software as medical device, according to Regulatory Focus.

The FDA will hire an additional 13 staff as technical experts to help the unit progress.

Patel said: “Because it’s such an emerging area, having a centralised unit in the Center Director’s Office is important for coordination on digital health topics and having consistency in applying policies.”

“The world of digital health has a lot of expertise that we need to supplement our organisation with.” He said.

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