NEW GUIDANCE! Manufacturers Sharing Patient Specific Information from Medical Devices with Patients upon Request  

On October 30^th, the FDA issued a new guidance detailing how manufacturers should share patient specific information from medical devices with patients upon request.  In many cases, patients express an interest in obtaining information which is retrieved from a legally marketed medical device and stored by the manufacturer in order to be able to play an active role in their own healthcare.  The more information a patient can obtain, the more they can engage with their healthcare provider in making sound medical decisions for themselves.  Some examples of patient-specific information can include data inputted in the device by a healthcare provider to record the status and ongoing treatment of an individual patient or information stored by the device to record usage, alarms, outputs, or case logs.

In most cases, a patient can go either to their healthcare provider or they can go directly to the manufacturer to obtain patient-specific information.  In general, manufacturers may share this information with the specific patient without undergoing any additional premarket review in advance.  If a manufacturer wishes to provide the patient with any supplemental information or materials that could be considered labeling, it would be subject to applicable requirements in the FD&C Act and FDA regulations.  Information provided by the manufacturer can be formatted to make it easier for a patient to understand.  It should be noted that even if a manufacturer provides patient-specific information to a patient, it is crucial for the patient to consult their healthcare provider in order to obtain proper context and interpretation.

 

? For any questions or comments or your regulatory requirement please email to info@mdiconsultants.com or use our contact form. and ref: Patient Specific Info