EMC OF MEDICAL DEVICES
Updated: Mar 3
U.S. Food and Drug Administration - Guidance for Industry.
EMC is the ability of a medical device to function safely and effectively in its intended electromagnetic environment without introducing excessive EM disturbances (i.e., emissions) that might interfere with other equipment. Immunity is the ability to protect against unacceptable degradation due to EM disturbances such as radio waves, power surges, radiofrequency (RF) disturbances, and electrostatic discharge (ESD).
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. It applies to medical devices, including in vitro diagnostic products and accessories that:
• are electrically powered, or
• have functions or sensors using electrical or electronic circuitry.
IEC 60601/806018 standards series apply to medical devices and systems that directly transfer energy to the patient, and the IEC 61010-1 standard applies to electrical laboratory equipment.
https://www.fda.gov/media/94758/download
eSTAR
FDA recognizes that the Agency and industry may require up to 1 year to complete activities to operationalize the policies contained in the guidance for in vitro diagnostic products only.
You can send medical device eSTAR and eCopy premarket submissions online. The eSTAR is an interactive PDF form that guides applicants in preparing a comprehensive medical device submission.
This template contains the following:
Automation (for example, form construction and autofill)
Content and structure that is complementary to CDRH internal review templates
Integration of multiple resources (for example, guidances and databases)
Guided construction for each submission section
Automatic verification
The eSTAR is free and available for voluntary use by all medical device applicants wishing to submit 510(k)s and De Novo requests to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER).
Starting October 1, 2023, all 510(k) submissions, unless exempted, must be submitted as electronic submissions using eSTAR.
Source: https://www.fda.gov/medical-devices/how-study-and-market-your-device/voluntary-estar-program