Subject: Docket FDA-2018-N-1315 Medical Device Safety Action Plan: Protecting
Patients and Promoting Public Health.
Dear Dr. Gottlieb,
The American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons
(CNS) appreciate the opportunity to provide our comments on the Food and Drug Administration’s
(FDA’s) recently released document entitled Medical Device Safety Action Plan: Protecting Patients and
Promoting Public Health. Neurosurgery has a long history of collaboration with the agency, as our
specialty, highly dependent on medical technology, is one of rapid innovation. We share the common
goal of improving patient safety while enhancing efficiency in bringing lifesaving improvements to our
patients.
Including Physicians as Partners for Device Safety
We commend the agency for undertaking a comprehensive approach to strengthen the infrastructure to
ensure medical device safety. However, we were concerned about the somewhat dismissive tenor of
comments regarding the existing Medical Device Reports (MDRs) submitted to the Manufacturer and
User Facility Device Experience Database (MAUDE) program, which are required of manufacturers, but
are voluntary for individual clinicians. The report states, “MDRs rely on a person, often a clinician, to
identify that a problem occurred, to realize that the problem may have been associated with the use of a
device, and to take the time to report the incident to FDA or the manufacturer.” The AANS and CNS
have encouraged its members to submit MDRs when appropriate, and we would argue that individual
physicians are uniquely qualified to provide such data to the FDA. We urge the FDA to continue the
program and enhance the voluntary mechanism for individual physicians to directly report device safety
concerns to the FDA. In addition, we appreciate the opportunity to provide neurosurgeon expertise to the
FDA for safety issues identified through the Signal Management Program. Finally, we encourage the
FDA to include physician specialty societies in the creation and implementation of new advisory activities
such as the CyberMed Safety Analysis Board.
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