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Yes, FDA registration for medical device establishments does have an expiry period. Here are the key points regarding the expiry of FDA registration:

1. Annual Renewal: FDA registration must be renewed annually. Medical device establishments are required to submit a renewal of their registration between October 1st and December 31st each year. This ensures that the FDA has current information about the facilities manufacturing or distributing medical devices in the United States.

2. Failure to Renew: If an establishment fails to renew its FDA registration by the deadline, the registration will expire. Once expired, the establishment may no longer legally manufacture, process, pack, or distribute medical devices in the United States until the registration is renewed.

3. Effect on Market Authorization: An expired FDA registration can impact market authorization for medical devices. Devices manufactured or distributed by an establishment with an expired registration may be considered misbranded or adulterated under FDA regulations, potentially leading to regulatory actions such as product recalls or market withdrawals.

4. Updating Information: In addition to annual renewal, establishments must update their FDA registration within 30 days of any changes to their operations or ownership that affect the accuracy of the registration information. This ensures that FDA has current and accurate information about the establishment's activities.

5. Notification of Renewal Status: FDA provides notification of the registration renewal status to establishments upon receipt of the renewal submission. Establishments are encouraged to maintain communication with FDA throughout the registration renewal process to ensure compliance with regulatory requirements.

Overall, maintaining an active FDA registration is essential for medical device establishments to continue marketing their products in the United States market legally. Timely renewal and updates to registration information help ensure compliance with FDA regulations and support ongoing market authorization for medical devices.

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