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Software Oversight Softened: FDA Nixes Medical Device Data Systems Enforcement

Makers of software that passively stores, transfers, formats or displays medical device data no longer need to worry about the quality system regulation or other basic device requirements for the products, according to a June 20 draft guidance.

Three years after establishing a class 1 regulatory policy for software that passively stores, transfers, formats or displays medical device data, FDA says enough is enough.

So-called medical device data systems (MDDS) are already exempt from pre-market review. But software makers will now no longer even need to worry about the quality system regulation or other...

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