The U.S. Food and Drug Administration (FDA) has issued a guidance document for medical device manufacturers on the recommended information that should be provided in premarket submissions filed with the agency to demonstrate electromagnetic compatibility (EMC) for electrically powered medical devices or devices with electrical or electronic functions.
Posted to the FDA website in mid-November, the guidance document embraces the “all-hazard approach” to device safety and encourages device manufacturers to provide EMC-related information in a number of specific areas, including:
- EMC-related device characteristics and intended use environments;
- A summary description of the potential risks to the performance of a medical device due to EMC disturbances;
- A list of all voluntary consensus standards used to evaluate EMC characteristics of the device;
- Clearly defined immunity pass/fail criteria;
- A description of the configuration, functions, modes, and settings that were evaluated during device testing; and
- A summary of the results of EMC emissions and immunity testing.
The FDA’s draft guidance document replaces the agency’s former guidance on the subject issued in July 2016.