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BioWorld - Saturday, March 28, 2026
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Home » New FDA MRI requirements mean all implants must be tested; not retroactive
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New FDA MRI requirements mean all implants must be tested; not retroactive

June 24, 2021
By Mark McCarty
The FDA’s device center recently updated its guidance for testing and labeling of devices for compatibility with magnetic resonance (MR) fields. Some items, such as orthopedic plates and screws, might not have been evaluated for compatibility up to now. The FDA’s Sunder Rajan said that existing 510(k) and PMA devices are grandfathered in under the legacy policy, but that all implants will have to be evaluated for MRI compatibility going forward, even devices not previously subject to testing.
Medical technology Regulatory U.S. FDA

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