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Need to recall Class I reusable devices to re-label them?
Medical Devices
Jul. 21th, 2023
No, you do not need to withdraw those devices that were placed on the market before May 26, 2020 under the MDD regime. This also includes reusable Class I devices. In general, medical devices legally placed on the market under the current MDD/AIMDD prior to May 25, 2020, may be supplied and placed into service until May 25, 2025.

No, you do not need to withdraw those devices that were placed on the market before May 26, 2020 under the MDD regime. This also includes reusable Class I devices. In general, medical devices legally placed on the market under the current MDD/AIMDD prior to May 25, 2020, may be supplied and placed into service until May 25, 2025.

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