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 of "excellence" in developing and evaluating products. As a result, pre-certified firms can benefit from a streamlined pre-market review process for new products
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