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2019 Will Be Testing Period For US FDA's Novel Pre-Cert Paradigm For Digital Health

In 2019, FDA will be taking steps to perform real-world testing of the effectiveness of its pre-cert program for health software and whether the program can be carried out within the agency's current regulatory authorities. The efforts come after more than a year of development and some pushback about statutory overreach and patient safety.

Medical app

US FDA says it will look to leverage its increasingly used de novo pathway as means to move forward with its ambitious Digital Health Software Precertification Program while staying within its existing statutory authorities. This update was included in one of a several documents posted this week to move the pre-cert program forward into a new testing phase after the past year of development.

The pre-cert program is intended as a pathway to a new regulatory paradigm for digital health products, where firms are pre-certified under an appraisal process that assesses a company's culture...

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