Federal regulators issued new recommendations this week designed to reduce the risk of medical devices causing electromagnetic interference, which may pose serious health risks.
The FDA released a draft guidance on Monday, focusing on the need for medical device manufacturers to demonstrate that products are electromagnetic compatibility, meaning they should not disrupt other nearby devices.
The guidance is not intended as a final ruling on the regulations, but a preliminary draft document, focusing on what information should be provided in a premarket submission application by manufacturers seeking FDA approval for new medical devices.
The recommendations do not constitute final FDA rules and are non-binding, but do act as strong guidelines for manufacturers to follow to avoid running afoul of regulatory issues.
As medical technology evolves, medical treatment increasingly relies on electrical medical devices. This means they can generate electromagnetic disturbance which may interfere with the performance of an electrically powered medical device in its intended environment or its intended use.
Some electronic medical devices may experience problems functioning in the presence of other electromagnetic interference. The draft guidance focuses on how to avoid the interference and create the optimal environment for medical devices to function, regardless of the presence of the presence of other electronic medical devices.
When finalized the draft guidance will replace the FDA guidance “Information to Support a Claim of Electromagnetic Compatibility of Electrically-Powered Medical Devices,” the 2016 Electromagnetic Compatibility (EMC) guidance published July 11, 2016.
The focus of the proposed guidance is to give additional technical information to address the recommendations for the 2016 EMC.
The guidance is considered preliminary until a final guidance has been issued by the FDA. The public comment period for the draft guidance extends for 60 days until January 19, 2021.
Comments can be submitted through a link on the draft guidance or can be submitted through the mail to Dockets Management, Food and Drug Administration, 5630 Fishers Lane, Rm 1061, Rockville, MD 20852. Written comments must be identified with the docket number: FDA-2015-D-3787. The draft guidance had not been published on the Federal Register as of press time.
Tags: Medical Devices