Medical Device Reporting Requirements

Medical device manufacturers are required to report to the Food and Drug Administration (“FDA”) within thirty days after receiving or otherwise becoming aware of information, from any source, that reasonably suggests that a device they manufacture may have caused or contributed to a serious injury or death, or has malfunctioned and the device or a similar device is likely to cause or contribute to a death or serious injury if the malfunction were to occur again. 21 C.F.R. § 803.50(a). The term “caused or contributed” is broadly defined as a death or serious injury that was or may have been attributable to a medical device or that a medical device was or may have been a factor in a death or serious injury.  21 C.F.R. § 803.3. Because the failure to comply with the reporting requirements are subject to FDA enforcement actions and sanctions under the Food, Drug & Cosmetic Act, medical devices manufacturers should not only be cognizant of their reporting requirements, but also the implications that these reports can have with respect to potential further actions by the FDA and potential product liability actions.
These reports can serve as the basis for FDA mandated “recalls” (which are defined in 21 C.F.R. § 7.40 as a method of removing or correcting the product). Under certain circumstances, manufacturers may wish to consider initiating voluntary recall efforts with the assistance and guidance of the FDA pursuant to 21 C.F.R. § 7.46. This may afford the manufacturer with a greater degree of control over the implementation and scope of the corrective measures than would otherwise be available if the FDA mandates that corrective actions be taken by the manufacturer. Voluntarily undertaking these measures may also place the manufacturer in a favorable light with the FDA and tends to transform the dynamic of the manufacturer’s relationship with the FDA to that of a partner as opposed to an adversary. Renzulli Law Firm has advised manufacturers who have been faced with product related issues that required analysis of a variety of potential corrective actions ranging from recalls to retrofit campaigns. In addition, Renzulli Law Firm has assisted manufacturers with developing and implementing product recalls, including a voluntary product withdrawal program that was developed for, and approved by, the U.S. Consumer Product Safety Commission.