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# FDA Designates 2 AAMI Consensus Standards
- URL: https://www.fdaweb.com/fda-designates-2-aami-consensus-standards/
- Published: 2020-01-30T12:00:00.000Z
- Updated: 2026-09-14T16:00:50.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145969

FDA has designated two Association for the Advancement of Medical Instrumentation standards as recognized consensus standards. By attaining FDA recognition, voluntary consensus standards can be used in premarket submissions to demonstrate conformity with relevant FDA regulations and requirements.

The two are the newly updated ANSI/AAMI/ISO 14971:2019, a fundamental risk management standard, and TIR97, which provides detailed guidance for addressing the unique challenges of maintaining the security of a medical device during its entire lifecycle.