The guidance examined whether manufacturers should share patient-specific information held in medical devices with patients upon request. Information that has been recorded, stored or processed in a medical device might include patient data or inputs by healthcare providers.
While not required under the Federal Food, Drug and Cosmetic Act, the FDA noted devicemakers are typically allowed to share patient-specific information with the patient without undergoing additional premarket review. However, manufacturers that choose to share information with patients should ensure the data is comprehensive and up-to-date, according to the agency.
The FDA also emphasized medical device manufacturers should encourage patients to speak with their respective physicians to discuss healthcare data obtained from their medical devices when appropriate.
“FDA recognizes the important role healthcare providers play in providing interpretation of and context to patient-specific information,” the recommendations read. “FDA recommends that manufacturers advise patients to contact their healthcare providers should they have any questions about their patient-specific information.”
To access the FDA guidance, click here.
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