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Guidance Issuing OfficeCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
This guidance document provides the FDA’s recommendations on testing to assess the electromagnetic compatibility of medical devices and information to include in the labeling. This guidance applies to medical devices, including in vitro diagnostics, and accessories that are electrically powered or have functions or sensors that are implemented using electrical or electronic circuitry. The recommendations are intended to promote consistency and facilitate efficient review of electromagnetic compatibility in device submissions.
FDA recognizes and anticipates that the Agency and industry may need up to 1 year to perform activities to operationalize the policies within the guidance, only for in vitro diagnostic products. Since this guidance generally reflects current practice for the assessment of EMC for other device types, but some activities to fully operationalize the policies are needed (e.g., updates to eSTAR), FDA intends to implement this guidance 60 days after issuance for device types within the scope of this guidance, excluding in vitro diagnostic products. If new information regarding electromagnetic compatibility as outlined in this guidance is not included in a premarket submission for an in vitro diagnostic received by FDA before or up to 1 year after the publication of this guidance or for other device types within the scope of this guidance before or up to 60 days after the publication of this guidance, CDRH staff does not generally intend to request such information during the review of the submission. CDRH does, however, intend to review any such information if submitted.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2015-D-3787.