Q: We’re planning a new venture to manufacture medical devices in the U.S. but export them only. There will be no commercial distribution in the U.S. and no marketing clearance in the U.S.
I understand that for other manufacturers with 510(k) approvals in the U.S., events that qualify under the Medical Device Reporting (MDR) regulations require us to submit an MDR report, no matter where the events occur, including outside the U.S. But in our case, if a manufacturer has no 510(k) and doesn’t distribute anything in the U.S., would we still need to file an MDR?
Consulting the regulations on the FDA website doesn’t help us. They make no distinction for situations like ours. It appears the regulations apply to all U.S. manufacturers of medical devices, even ones like us who would export all devices with no commercial distribution or market clearance in the U.S. Can you help clarify FDA’s expectations in a case like ours?
A: The FDA website is meant to clarify what might not be clear from reading the regulations themselves. Medical Device Reporting is only required for devices distributed in the U.S., no matter where they are made. In this case, the U.S. includes all 50 states, Puerto Rico, and other U.S. territories and commonwealths (U.S. Virgin Islands, Guam, American Samoa, etc.) plus all U.S. military installations, no matter where they’re located.
[pullquote align=”right” cite=”” link=”” color=”” class=”” size=””]You will be required to submit vigilance reports to the various countries where your product is distributed….[/pullquote]
If you don’t distribute your product to any of the locations described above, then FDA’s Medical Device Reporting regulations don’t apply. You will, however, be required to submit vigilance reports to the various countries where your product is distributed in accordance with those countries’ own regulations and requirements.
But don’t think you’re totally out of FDA’s jurisdiction. I’m assuming you will be registered with the FDA as a medical device manufacturer, because that’s the law. If any of those other countries ever receive a report about your device and want more information about your company, they may contact the FDA. In that case, FDA will inspect you as needed and will assist foreign governments if requested.
Answered by Denise Dion, Vice President of Regulatory & Quality Services at EduQuest (18 years as an expert FDA field investigator and a co-developer and trainer of FDA’s Quality System Inspection Technique-QSIT). Denise also is the lead instructor for EduQuest’s two-day training class on QSR Compliance Basics: Complying with FDA’s Medical Device 21 CFR 820 Quality System Regulation,