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# FDA, Other Regulators Back Standardized Device Reporting
- URL: https://www.fdaweb.com/fda-other-regulators-back-standardized-device-reporting/
- Published: 2017-04-10T12:00:00.000Z
- Updated: 2026-09-14T22:16:59.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138418

FDA and other regulatory bodies participating under the International Medical Device Regulators Forum (IMDRF) have released a final guidance document on “IMDRF Terminologies for Categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes.” Widespread use of a single adverse event terminology and coding system could improve signal detection by adverse event management systems and thus enable a faster response by both industry and regulatory agencies. For manufacturers, having standardized terms and coding will reduce the burden of managing multiple coding systems when preparing medical device adverse event reports for multiple jurisdictions, they say. To view the guidance, click [here](http://www.imdrf.org/docs/imdrf/final/technical/imdrf-tech-170316-aer-n43.pdf?ref=fdaweb.com).