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Bakul Patel, Jeffrey Shuren: FDA Adjusts Regulatory Approach for Medical Device Data Systems

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health infosecThe U.S. Food and Drug Administration has decided not to regulate medical technologies intended to store, display and transfer health information because FDA believes the devices pose a low risk to users.

The new policy is stated in the agency’s final guidance for medical device data systems and designed to encourage healthcare information technology development while ensuring patient safety, according to a Feb. 16 blog post by Jeffrey Shuren and Bakul Patel of FDA’s Center for Devices and Radiological Health.

“FDA seeks to advance public health by promoting innovation and development in this area by continually adapting our regulatory approach to technological advances to meet the needs of patients and consumers,” they wrote.

Shuren and Patel said the agency also updated guidelines for mobile medical applications to be consistent with the finalized MDDS regulatory framework.

FDA also drafted two guidance documents to address the agency’s policy for general wellness products and medical device accessories.

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