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Size Doesn't Matter: US FDA Refines Dig-Health Pre-Cert Model

After receiving feedback from industry and other stakeholders, FDA has revised its "working model" for its planned pre-certification program for health software. It now states that size of a company will not preclude them from participating in the program. The agency has also refined how it will conduct appraisals.

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A new working model document shows how FDA is evolving its thinking on the much anticipated pre-certification program. The agency published the updated document on June 19, including new metrics and processes that the device center will use when evaluating software as medical device (SaMD) that qualify for the program.

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