The federal safety watchdog’s draft guidance for “Medical Device Reporting for Manufacturers,” issued in July 2013, put both the contract manufacturer and its customer on the hook for reporting adverse events:
“For devices manufactured under contract, both the firm that actually manufactured the device (‘Firm A’) and the firm that initiated the specifications and distributed the device (‘Firm B’) are considered a ‘manufacturer,'” according to the draft guidance. “[B]oth the firm that manufactures the device and the firm that initiates the specifications for the device are manufacturers who are required to report.”
But the final guidance, issued Nov. 8, defines “manufacturer” as including “a firm that initiates specifications for devices that are manufactured by a 2nd party for subsequent distribution by the person initiating the specifications,” distinguished from contract manufacturers that merely fabricate the device.
“A contract manufacturer who does not distribute or market the devices it manufactures for a specifications developer would not have an MDR reporting obligation … and would not require an exemption,” according to the final guidance. “However, if the contract manufacturer (Firm A) distributes or markets the devices that it manufactures for the specifications developer (Firm B), then both would have an MDR reporting obligation.”
The final guidance also clarifies the reporting of user error, saying that because error could “reflect problems with device labeling, the user interface, or other aspects of device design” it should “be reported in the same way as other adverse events which are caused or contributed to by the device.”
But the final draft adds, “If you determine that an event is solely the result of user error with no other performance issue, and there has been no device-related death or serious injury, you are not required to submit an MDR report, but you should retain the supporting information in your complaint files.”