The U.S. Food and Drug Administration has issued final guidance documents that take a noticeably lighter regulatory hand when it comes to medical device data systems and mobile applications.

MDDS is hardware or software that transfers, stores, converts formats, and displays medical device data from a variety of other devices including glucose meters, blood pressure cuffs, and weight scales. However, in guidance published today in the Federal Register, FDA states that it does not intend to enforce compliance with the regulatory requirements that apply to MDDS, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers of these types of devices.

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