Gottlieb Pledges Further Details About Precertification Program

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.

“Moving forward, the FDA will continue to update this report to ensure the agency is striking the right balance in our approach to digital health,” Gottlieb said.

Read the new report here: www.fdanews.com/12-13-18-SoftwareFunctions.pdf. — Zack Budryk