Inspections, Compliance, Enforcement, and Criminal Investigations
GUIDE TO INSPECTIONS OF ELECTROMAGNETIC
COMPATIBILITY ASPECTS OF MEDICAL DEVICE
example, the interface with other medical devices or the interference from other consumer products?
- If complaint or failure data for similar devices distributed by the manufacturer indicated EMCproblems, did the manufacturer use this information in establishing the design requirements for the new device?
- Identify any relevant EMC standard(s) used as a part of the design input process."
AT THIS TIME FDA DOES NOT REQUIRE CONFORMANCE TO ANY EMC STANDARDS. HOWEVER EMC SHOULD BE ADDRESSED DURING THE DESIGN OF NEW DEVICES OR REDESIGN OF EXISTING DEVICES, ESPECIALLY IF EMC INFORMATION HAS BEEN REQUIRED FOR PREMARKET CLEARANCE.
In the DCIS, Investigators are asked to determine during an inspection of design control activities what, if anything, manufacturers are doing to design electrical and electronic devices for EMC. The most significant phases where EMC should be addressed are design input and design verification. If reports of EMI implicate either a design problem or any other GMP problem, the investigator may find the questions in Appendix E helpful in guiding the inspection. Appendix E is to be used only for help in understanding the application of the DCIS to EMC issues, not for reporting findings of the inspection.
21 CFR 820.30(c) Design Input
It is important for a manufacturer of electrical devices to determine how EMC will be addressed with regard to the device use environment. Possible EMD - from and to other medical devices or from consumer electronic products, commercial and private radio transmissions, power line disturbances, and ESD - needs to be evaluated.
Example: A ventilator is likely to be used in conjunction with other devices such as patient monitors. The ventilator performance may be affected by EMD from other devices and/or non-device sources such as cellular phones or two-way radios. The ventilator may emit EMD which interferes with other devices used in the same area.
A manufacturer may have complaint, failure, or service data or have experience with device performance problems caused by EMI. Such information should be used in establishing the design specifications of the redesigned device.
If a manually operated device is being redesigned to add electronic controls, the manufacturer may not have any past experience with EMI problems with that device. Research will be needed to identify sources of EMD in the use environment. The same is true for a totally new device. MDR reports from other manufacturers' similar devices may be helpful in identifying EMI problems.
The firm also should have criteria for deciding when and how EMC will be addressed in labeling in addition to the product design.
21 CFR 820.30(d) Design Output
The design system should identify and define the design output in regard to EMC. Components such as cables and housing may have shielding to protect the device from EMD. The output must be defined in terms of measurable performance of the device so that appropriate testing and verification can be performed. Thus EMC may be addressed through a combination of specifications for components and performance requirements for sub-assemblies and the finished device.
21 CFR 820.30(f) Design Verification
Verification methods and activities are required to confirm that input requirements for EMChave been fulfilled by design output. Verification will often be a physical test of the product, a subassembly or component of the product to determine if the specified EMC criteria or specification (design input) was met by the final design (design output). If design input includes specifications based on requirements in IEC 60601-1-2 or other EMC standards, the firm should determine who will test the design output