By Robert J. Kerwin

Medical device manufacturers, importers, distributors and user facilities have long been required to report deaths, serious injuries and malfunctions that have, may have or would be likely to cause or contribute to a death or serious injury. The FDA regulation pertaining to “user facilities” provides that reports should be filed on the FDA’s MedWatch Form 3500A or an electronic equivalent.

This MedWatch form was recently changed to add in a question that inquires whether the equipment was serviced by a third party. Specifically, Part D, Section 8 now includes the question: “[w]as this device serviced by a third party”?

The MedWatch program was established over 25 years ago to assist the FDA in collecting data on adverse events in the healthcare industry. While the MedWatch form 3500A continues to ask the reporter of the adverse event to complete several categories such as “patient information”, adverse event or product problem and several other categories including details about the medical device that is suspected to have contributed to the adverse event, this appears to be the first time that the Form 3500A includes a question inquiring as to whether the device was serviced by a third party.

No FDA guidance was included as to this new section or as to why the change was recently made. Some knowledgeable observers are suggesting that it would be helpful for the FDA to provide additional guidance or information.

About the author: Robert Kerwin is general counsel to IAMERS and has served in that capacity for over twenty-five years.

This article is reprinted with permission of DOTmed HealthCare Business News and can be read online in its original format at: