QUOTED. April 16, 2019. Bakul Patel.
Executive Summary
The US FDA's top digital health officer, Bakul Patel, has been talking to regulators from Canada, Singapore and Japan that are interested in learning more about the agency’s pre-cert pilot program. See what Patel said here.
"There are a lot of people who have been observing what we're doing. [Other regulators] may be still trying to figure out how to translate [the precertification program] into their laws or legal structure, but everybody is very interested. At least that's what's the impression I get." – Bakul Patel, associate director of digital health, US FDA's Center for Devices and Radiological Health
- Find out more: If You Build It, They Will Come: FDAer Says Pre-Cert Program Getting Global Attention, AI Paper Just the Start
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