Maintaining its steady pace of modernizing medical device policies, the FDA finalized new guidance designed to ensure patients have access to data stored in medical devices.
The guidance, drafted in June 2016 after reports surfaced that patients were unable to obtain the data generated by implanted devices like pacemakers, encourages manufacturers to share patient data whenever feasible. Although some manufacturers previously argued that turning over patient information would require FDA approval, the finalized guidance (PDF) solidifies the agency’s position that companies can share data at the request of a patient without undergoing an additional premarket review.
