U.S. FDA relaxes regulatory requirements for medical device data systems

The Emergo Group Blog provides short updates on quality and regulatory topics that may be of interest to QA/RA professionals in the medical device and IVD industry. No fluff, just straight to the point. We hope you'll enjoy the content.

By Stewart Eisenhart, Emergo Group

Medical device data systems (MDDS) used to support digital health technologies will no longer be required to comply with the US Food and Drug Administration's regulatory controls, according to new guidance from the agency.

Emergo Group, Food & Drug Administration (FDA)

News Well, Blog, Food & Drug Administration (FDA), Health Information Technology, Regulatory/Compliance

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