Under the U.S. Food and Drug Administration’s (FDA) Medical Device Reporting (MDR) Regulation, 21 C.F.R. Part 803, medical device manufacturers must report adverse events involving their devices to FDA when information reasonably suggests that:
- Their device may have caused or contributed to a death or serious injury; or
- Their device has malfunctioned, and it or a similar company device would likely cause or contribute to a death or serious injury if the malfunction were to recur.
FDA’s long-standing policy has been that a manufacturer must report such adverse events occurring outside the United States, under the MDR Regulation, if the same or a similar device is marketed by the manufacturer in the U.S. The rationale has always been that such foreign adverse events are relevant to the Agency’s assessment of the safety and effectiveness of the same or a similar device marketed by the manufacturer in the U.S. The Agency most recently articulated its position in its latest draft MDR guidance:
. . . FDA considers an event that occurs in a foreign country reportable under the MDR regulation if it involves a device that has been cleared or approved in the U.S. — or a device similar to a device marketed by the manufacturer that has been cleared or approved in the U.S. — and is also lawfully marketed in a foreign country. Devices may be manufactured to slightly modified specifications to meet standards in different countries. If these changes do not substantially alter the performance of the device, then any adverse events that are MDR reportable events relating to such modified devices should be reported under the MDR regulation . . .
See “Draft Guidance for Industry and Food and Drug Administration Staff: Medical Device Reporting for Manufacturers” (issued on July 9, 2013) at page 33. This seems to be a reasonable requirement where foreign events are relevant to the safety and effectiveness of the U.S. marketed device. However, the Agency takes its policy further. FDA has the following Q&A in the latest draft MDR guidance:
4.12.1 If I previously marketed a device that is still in commercial distribution, but have ceased manufacturing the device, do I still have an obligation to submit MDR reportable events?
Yes, as long as you remain in business, you have an obligation to report events involving any device that you manufactured, even if you cease marketing the device. Note that you are not responsible for MDR reporting if you transfer ownership of a PMA or 510(k) for one of your devices to another company, and the new owner explicitly agrees to be responsible for MDR reporting obligations. Both firms should maintain documentation of this arrangement for MDR reporting.
Id. at page 34. According to FDA, this obligation to report foreign adverse events persists even if the manufacturer can demonstrate that no units of the same or similar device remain in the field in the U.S. or can demonstrate that the design and expected life of the last unit of a same or similar device, distributed in the U.S., has expired. FDA takes the position that, if the product has been approved or cleared for marketing in the U.S., resumption of such marketing could take place at any time, making the interim foreign adverse events relevant to assessing the overall safety and effectiveness of the U.S. version of the device once U.S. distribution is resumed.
Obviously, the most conservative approach is to accept FDA’s interpretation and continue to file foreign adverse events until you go out of business or some new owner assumes responsibility. This is the easiest approach to avoid potential disagreements with FDA over foreign event MDRs down the road. However, if one were to be more aggressive, one might question whether FDA has a substantial governmental interest in receiving reports of foreign adverse events when there are no same or similar products in the field in the U.S. anymore or when the design and expected life of all such U.S. units has expired. Arguably, there is only a hypothetical possibility that U.S. marketing of the same or a similar device will resume at some point in the future. One might even wonder whether FDA’s policy would stand up to a legal challenge.
Finally, the policy is written in terms of products which are PMA-approved or 510(k)-cleared for marketing in the U.S. It leaves open the question of how 510(k)-exempt products are affected by the policy.
MDR reporting plays an important role in the FDA device regulatory scheme as the Agency strives to monitor the safety and effectiveness of medical devices marketed in the U.S. However, reasonable minds could differ over when a reporting obligation should end, especially in the above context.