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US FDA's Software Pre-Cert Program: Is The Authority On The Books?

The agency is building its pre-certification program as a novel paradigm for health software products to reach the market with less scrutiny when companies successfully undergo "excellence" appraisals. It has attracted the interest and support of many stakeholders, but at least one medtech group argues the agency should have to get congressional approval to launch the program.

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Device and digital-health firms are looking toward US FDA's imminent launch of the novel pre-certification program as an opportunity to streamline the path to market for new software. FDA has been regularly engaging stakeholders during the pilot stage with a goal to quickly get the first iteration of the program off the ground.

As part of the effort, the agency says it is carefully designing the program to fit within its current legal authorities. (Also see "Size Doesn't Matter: US FDA Refines Dig-Health Pre-Cert Model" - Medtech Insight, 20 June, 2018.) But not everyone agrees it is meeting that standard

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