Sharing information collected by medical devices with patients “may assist them in becoming more engaged with their healthcare providers in making sound medical decisions,” the FDA said in guidance for device manufacturers.
The guidance, which follows on a 2016 draft, addresses cases in which patients request the information, such as pulse oximetry data, heart electrical activity and rhythms monitored by a pacemaker.
Although not required to do so by law, manufacturers generally may share such information without obtaining FDA clearance in advice, the agency said, and the information won’t be subject to labeling regulations.
Read the guidance here: www.fdanews.com/10-27-17-MedicalDevices.pdf. — Gregory Roberts