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: Some certificates are issued for specific series or lots and may have hard expiration dates, such as January 1, 2025 , after which new registration is required for continued sale. Critical Updates for 2024–2026
: Without an updated certificate, products cannot be legally sold or used in clinical settings.
If you are managing a device under the ROE024RM designation, follow these steps to ensure you are current: Medical Devices - FDA
Several major regulatory shifts have impacted how devices like those covered by ROE024RM are registered and maintained: