CDRH Clarifies When Device MDR Reporting is Required

CDRH says it does not require device makers to file Medical Device Reporting (MDR) submissions if their device is being used outside the U.S. for a different intended use and the malfunction or death or serious injury are related to that different use — and not the same use that it is used for in the U.S. The Center made this distinction during a recent conference call (view transcript) about a final guidance on “Medical Device Reporting for Manufacturers.” But if the device is being used under the same conditions and indications in the U.S. then it would be reportable, CDRH MDR Policy Branch expert Bill Maloney said. Later in the call, Maloney said that if a device is being used off-label and there is a death or serious injury, then an MDR report is required.

The guidance was issued last month and is intended to help companies meet applicable reporting and recordkeeping requirements for certain device-related adverse events and malfunctions. The document covers MDR requirements to develop, maintain, and implement written procedures for identifying and evaluating all medical device events (e.g., malfunctions, serious injuries and deaths) to determine whether the event is an MDR reportable event. It also covers requirements to establish and maintain complete files for all complaints concerning medical device events.

Additionally, the guidance focuses on common errors in MDR reports. For example, it says a common error is duplicate report sequence numbers provided in the Manufacturer Report Number box and Block G-9. “Each report must have its own sequence number to avoid confusion,” it says. “You should not use the same sequence number on more than one report in any given year.” Another common error is having multiple devices or events included in the same report. “If more than one of your devices is involved in a single MDR reportable event, and it is not apparent which device may have caused or contributed to the event, then you must submit a separate report for each of your devices involved in the event,” the document says.

During the conference call question and answer session, CDRH was asked whether firms are required to report MDRs on products that are manufactured outside the U.S. if they are currently sold outside the U.S., but not yet sold and marketed in the U.S. although they are registered for sale in the U.S. Center experts said MDR reports are still required — “if you’re registering in the U.S. you could potentially market it here.”

CDRH was also asked whether a malfunction is considered an adverse event like an injury or death? “We consider adverse events to be death, serious injury, and some malfunctions,” MDR expert Isaac Chang said. “We are interested in hearing about all of them” because reportable malfunctions are situations that may cause or contribute to a death or serious injury if they occur, he said.

The MDR experts said additional questions should be sent to the Center’s help desk email: MDRPolicy@fda.hhs.gov.