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What is the validity period for FDA registration and certification in the United States?
Category：行業(yè)資訊 Date：2024-08-20 16:50:19 Author: Source:
Overall, while the validity period for FDA registrations and certifications varies, continuous compliance and timely renewals are essential to maintaining authorization to market products in the U.S.

The validity period for FDA registration and certification varies depending on the type of product and registration. Here’s a detailed overview:2(1).jpg

1. Medical Devices

  • Establishment Registration: The registration of a manufacturing facility is valid for one year. It must be renewed annually by updating the registration details through the FDA’s registration portal.

  • Device Listing: Device listings are also valid for one year. Manufacturers need to update their device listings annually to keep them current and accurate.

2. Drugs

  • New Drug Application (NDA) and Abbreviated New Drug Application (ANDA): Once approved, the NDA or ANDA remains valid as long as the drug product continues to meet FDA requirements and is marketed. However, periodic re-evaluation and renewals may be required, especially if there are significant changes to the product or its manufacturing process.

3. Biologics

  • Biologics License Application (BLA): A BLA remains valid as long as the product continues to meet FDA regulations and is marketed. Similar to drugs, periodic reviews and renewals might be necessary based on changes or updates to the product.

4. Food and Dietary Supplements

  • Food Facility Registration: This registration is valid for two years. Facilities must renew their registration every two years through the FDA’s registration portal.

  • Dietary Supplement New Ingredient Notification: Once submitted and acknowledged, the notification does not expire, but manufacturers must ensure ongoing compliance with FDA regulations.

Key Points

  • Renewal: For most registrations, timely renewal is crucial to maintaining validity. Failure to renew can result in the loss of registration status and potential legal and operational consequences.

  • Updates: Regular updates to registration details, device listings, and other relevant information are required to ensure continued compliance.

  • Compliance: Maintaining compliance with FDA regulations is necessary to keep the registration or certification valid. Changes in product formulation, manufacturing processes, or labeling may require new submissions or amendments.

Overall, while the validity period for FDA registrations and certifications varies, continuous compliance and timely renewals are essential to maintaining authorization to market products in the U.S.

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