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Medical Devices / Regulatory Affairs

Gottlieb Pledges Further Details About Testing Plan for Precertification Program

Dec. 19, 2018

FDA Commissioner Scott Gottlieb said the agency plans to release more details in the coming weeks about its precertification program for digital health technology, including details of the agency’s testing plan for products in 2019.

Gottlieb made the announcement in the context of a new report last week by the agency on non-device software, which spells out the distinction between device and non-device software for regulatory purposes.

Unlike medical device software, health product software relates to maintaining or encouraging a healthy lifestyle.

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