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GUIDE TO INSPECTIONS OF ELECTROMAGNETIC COMPATIBILITY ASPECTS OF MEDICAL DEVICE QUALITY SYSTEMS | 1 |
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This guide was prepared by the FDA, Office of Regulatory Affairs, and the Center for Devices and Radiological Health (CDRH), Office of Compliance. This guide provides FDA investigators with information regarding electromagnetic compatibility (EMC) and how it is likely to be addressed in a medical device firm's Quality System/Good Manufacturing Practices (QS/GMP) (21 CFR Part 820). Terms throughout this document that are in bold typeface are defined in Appendix A. THIS DOCUMENT APPLIES ONLY TO ELECTRICALLY POWERED (MAINS OR BATTERY) DEVICES. It includes information on the following:
The Center for Devices and Radiological Health (CDRH) is encouraging firms, many of whom have never considered some of these issues, to begin the process of addressing EMC. The goal is to improve the industry norm, not to penalize industry efforts to design EMC into their devices. There are a number of confounding factors in achieving EMC. Manufacturers can design EMCinto their electrical devices for most expected use environments, depending on design options for proper functioning or electrical safety, intensity or variableness of environments, the |
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