RED HOT Contributors


FDA releases med device company patient data sharing guidelines


FDA medical device recalls

The FDA this week released guidance clarifying its position on sharing patient-specific information gathered by medical devices, saying it supports the release of such information by device developers at a patient’s request.

The agency clarified that it sees “patient-specific information” as information “unique to an individual patient or unique to that’s patient’s treatment or diagnosis that has been recorded, stored, processed, retrieved, and/or derived from a legally marketed medical device.”

The FDA said that device companies that choose to release such information can “do so without undergoing additional premarket review in advance,” and that it would not consider patient-specific information to be “labeling.”

The agency said that for any information shared, it should be “comprehensive and contemporary.”

“For example, if a patient requests from a manufacturer a history of her own blood pressure measurements from a device, the data should include all available data up through the most recent measurement. Manufacturers may also format the patient-specific information to facilitate its usability by the patient,” the FDA wrote in its guidelines.

The federal watchdog added that while it supports manufacturer-shared information with patients if the patient requests such data, such companies would not be required to do so.

For data that is difficult to share with patients due to its format or for data that would require redesigned devices to convey such information, the FDA said that a company should not feel inclined to share it.


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