On July 8, 2013, the Food and Drug Administration (FDA) announced the availability of a draft guidance, “Medical Device Reporting for Manufacturers,” which when final, will supersede the 1997 version. The draft addresses specific questions about the reporting and recordkeeping requirements for device-related adverse events.
The draft significantly expands on the earlier guidance for manufacturers and attempts to respond to the practical concerns of industry. For example, it includes recommendations concerning:
- evaluating differences of medical opinion;
- conducting follow up investigations;
- determining the expected life of the device;
- reporting events for devices marketed only in foreign countries;
- reporting events for devices that are no longer being manufactured;
- allocating responsibility for reporting after a 510(k) has been transferred to another firm; and
- dealing with patient confidentiality rules in health care settings.
One of the most difficult issues manufacturers face is determining whether an event is reportable. The draft contains some suggestions on this topic, including events involving:
- a delay in surgery;
- the failure of a diagnostic device; and
- incorrect treatment with a radiation therapy device.
The draft makes additional practical recommendations concerning the information that should be submitted in the different blocks on the MedWatch Form 3500A. Finally, the draft makes clear that certain changes to MDR reporting proposed by Congress in the Food and Drug Administration Amendments Act of 2007 have not been implemented by FDA. The result is that malfunction reporting requirements for class I and those class II devices that are not permanently implantable, life supporting or life sustaining, continue to be subject to the MDR reporting requirements of 21 C.F.R. part 803.
The draft guidance is available here. Comments should be submitted by October 7, 2013.