FDA’s New MDDS Rule Finalized

Final rules to expedite medical device data systems’ (MDDS) path to market in the US have been issued by the Food and Drug Administration (FDA). MDDS products include hardware and software used to display, transfer or store unaltered medical device data. Under the new rule, such devices now fall under the Class I low-risk category, effectively exempting them from premarket review while still requiring them to conform to quality standards. Previously, the FDA typically classified MDDS products either as Class III devices or as accessories to existing medical devices. Under the Class I designation, all medical device manufacturers and information technology providers developing MDDS products must register with the FDA, list their appropriate MDDS products, report any adverse events and meet quality system requirements. Taken together with the agency’s 510(k) process.

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