The FDA's pilot program for pre-certification of software-based medical devices, which will begin in September with up to nine participating companies, will use software design, validation and maintenance as basis for assessing developers' compliance with quality standards, Commissioner Scott Gottlieb wrote Thursday in a blog post. A draft guidance for medical device data systems, medical image storage and communications devices, mobile medical apps and other products will also be released by the year's end as part of the agency's digital health efforts.
Gottlieb unveils details on FDA's plans for digital health regulation
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