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# FDA Needs More Digital Power: Patel
- URL: https://www.fdaweb.com/fda-needs-more-digital-power-patel/
- Published: 2022-05-10T12:00:00.000Z
- Updated: 2026-09-14T17:44:06.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151778

In a Regulatory Affairs Professional Society interview, outgoing FDA Digital Health Center of Excellence director **Bakul Patel** says the agency needs additional Congressional authorities for its digital health products pathway and other digital programs. In the online interview, he [said](https://www.raps.org/news-and-articles/news-articles/2022/5/outgoing-cdrh-digital-health-chief-pre-cert-needs?feed=Regulatory-Focus&ref=fdaweb.com) the authorities FDA needs include being able to use real-world evidence generated from digital health products that can be incorporated into marketing authorization decisions.

“Moving to a continuous oversight mechanism will take additional congressional authorities,” he said. Other authorities he said are needed include being able to rely on a company’s appraisal to determine whether a product goes to market and being able to require companies to report what they are learning about their product based on real-world evidence. He also said it’s important that FDA implement the International Medical Device Regulators Forum’s risk-based framework for software as a medical device.

Patel said the agency should take its experience with digital health regulation and apply it beyond CDRH to other parts of FDA. He also called on manufacturers to understand that FDA shares their intent to get the best products out to patients in the best possible way and said companies need to be open and transparent with the agency so they can work together to reach their common goals. “If industry invests in the digital nature of their products with analytics, I think that will be the best way forward for them,” he said.

Patel indicated it was difficult to leave FDA after 13 years, but he wanted to take his years of experience there to the next level and is considering several private sector opportunities.