FDA Finalizes Two Guidances on Sharing Device Data With Patients, Aspirator Device Labeling
Posted 27 October 2017 | By
The US Food and Drug Administration (FDA) on Friday finalized two guidance documents, including one related to medical device manufacturers sharing information with patients upon request, and another to recommend the addition of a specific safety statement to the product labeling of certain ultrasonic surgical aspirator devices.
Sharing Patient Info
The five-page guidance, first released as a draft in June 2016, is meant to convey FDA's position on manufacturers "appropriately and responsibly" sharing patient-specific information with a patient at his or her request.
"In general, manufacturers may do so without undergoing additional premarket review in advance," FDA says, while acknowledging industry comments, and noting that some devices record or transmit information in a format that is not easily provided to the patient, while others record and retain information in a closed system that is not accessible by the manufacturer.
"Generally, if patient-specific information is shared with patients by manufacturers, 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 final guidance notes.
Ultrasonic Surgical Aspirator Devices
Another five-page final guidance, first drafted last November, recommends that manufacturers of ultrasonic surgical aspirator devices with indications for use in laparoscopic surgery, open surgery or gynecologic surgery prominently include the following contraindication in their product labeling:
"CONTRAINDICATION: This ultrasonic surgical aspirator device is not indicated for and should not be used for the fragmentation, emulsification, and aspiration of uterine fibroids."
FDA says it recommends that manufacturers review and update other portions of their labeling to be consistent with this contraindication. "For example, a manufacturer may revise the list of procedures in the labeling for which the ultrasonic surgical aspirator can be utilized," the guidance says.
Manufacturers Sharing Patient-Specific Information from Medical Devices with Patients Upon Request Guidance for
Industry and Food and Drug Administration Staff
Product Labeling for Certain Ultrasonic Surgical Aspirator Devices Guidance for Industry and Food and Drug Administration Staff