First, I presume that your question is limited to FDA's Medical Device Reporting (MDR) requirements in 21 CFR Part 803 rather than FDA's 21 CFR Part 806 requirements for reports of correction or removal. The Part 806 reporting regulations are different and have different intentions. The remainder of this narrative is focused on Part 803 reporting.
In somewhat plain terms, the bottom line is that if a foreign adverse event happens with, or that is relevant to, your device model/type that is legally marketed in the U.S., and if the nature and details of the foreign adverse event meet FDA's MDR reportability criteria, then yes, a corresponding MDR report for the foreign event must be submitted to the FDA. An example of FDA's stance on this can be found in section 4.11 of FDA's MDR guidance document. That foreign event reporting requirement is rooted back to a 1984 regulatory preamble when FDA established that such foreign event reports were required under the Part 803 regulation. Note that these foreign event reporting requirements also apply to devices made in the U.S. for export pursuant to sections 801(e) and 802 of the FD&C Act.
Remember that FDA's MDR reporting triggers aren't contingent on whether a report was made to or from a foreign authority. Instead, FDA's triggers are contingent on the nature and details of the foreign event and its relevance to your device models/types that are legally marketed in the U.S., or that are made in the U.S. and exported under sections 801(e) and 802 of the FD&C Act. Consequently, I don't believe you'll find FDA guidance for FDA MDR reporting triggers in terms of whether a report was made to, or from, a foreign authority. This is an interesting difference when compared to, for example, Health Canada, who does have such a reporting trigger.
I'll wait to give further explanations depending on this thread's progression. But in parting, I will say for now that just because the event reportability criteria of a foreign government have been met, that doesn't necessarily mean that the reportability criteria of the U.S. FDA have been met. Indeed, when evaluating a foreign event or feedback to determine FDA MDR reportability, it is important to filter and assess the event/feedback through the lens and terminology of the U.S. FDA. Indeed, different jurisdictions use varying terminology and reportability thresholds. Accordingly, hybridized terminology is not recommended, as it will inevitably lead to under-reporting or over-reporting. The best way is to keep your adverse event reporting procedures separate for each jurisdiction. For example, your narrative "an incident was reported to a foreign authority" is ambiguous for the purposes of FDA MDR reporting because FDA doesn't use or define the term "incident". Moreover, foreign authorities may have different terms such as "serious incident" (EU MDR). Further, although the term "incident" is used by various foreign authorities, they have varying definitions for that term. For example, Health Canada's definition of "incident" is different than the UK's. Therefore, using those terms as a filter for U.S. MDR reporting will cause the manufacture to deviate from FDA's U.S. MDR reporting obligations.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 06-Jul-2022 12:08
From: Anonymous Member
Subject: Third Country Reporting
This message was posted by a user wishing to remain anonymous
Looking for feedback:
Does the FDA require reporting when a U.S manufacturer is notified that an incident was reported to a foreign authority?
If a U.S manufacturer gets a report from a foreign authority, is the manufacturer required to report to the FDA as well?
The FDA Med Dev Reporting guidance does not clearly state scenarios for these questions.