Page 76 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 55

Complaint records must be available at the manufacturing site. If your complaint analysis is done
at a different location, the records must be made available. In paper records this often meant dupli-
cating the paper records at the manufacturing site. With electronic systems, it is easier to provide
access to complaint records at all site.

Subpart N: Servicing. If servicing is part of your device requirements, you must establish servicing
∗
procedures. Servicing interacts with other areas of the QSR. For example, service reports must be
analyzed to see if they must be analyzed under a CAPA procedure, including statistical analysis for
frequency, etc. Some service reports may be reportable as MDRs. These automatically are classified
as complaints under subpart L.
Records must be kept of each service including
(1) The name of the device serviced;
(2) Any device identification(s) and control number(s) used;
(3) The date of service;
(4) The individual(s) servicing the device;
(5) The service performed; and
(6) The test and inspection data.
Id. § 820.200(d).

Subpart O: Statistical Techniques. Manufactures must establish procedures for “identifying valid
statistical techniques required for establishing, controlling, and verifying the acceptability of process
†
capability and product characteristics.” Sampling plans must be based upon a valid statistical ratio-
nale and must be adequate for the intended use.

2.15 MEDICAL DEVICE REPORTING

Medical Device Reporting (MDR) is a reporting system for collecting serious adverse events related
‡
to commercially used devices. This regulation does not cover clinical devices. Adverse events for
clinical trials are reported as part of the IDE system.
Congress established MDR reporting so that FDA would be aware of serious events in the field.
The MDR system requires reporting from user facilities, importers, and manufacturers. These reports
are done on an FDA form called MedWatch.
The events that must be reported are
• Deaths.
• Serious injury, meaning one that is life-threatening, results in permanent impairment of a body
function, or permanent damage to a body structure.
• Malfunctions of a device that, if it were to recur, would be likely to cause or contribute to a death
or serious injury.
FDA has taken a fairly expansive view of these definitions in an attempt to get broad reporting.
For example, the practical usage of the term “would be likely” is “might.”
The definitions of who must report are also wide:

*
Id. § 820.200.
†
Id. § 820.250.
‡
Id. pt. 803.