The U.S. Food and Drug Administration (FDA) does not issue a uniform "FDA certificate," but instead issues different types of approvals, licenses, or notices depending on the product type and certification process. As a result, the validity period of the certificate will vary depending on the type of product and the type of certification.
Here are some common FDA certification and approval validity scenarios:
1.510(k) Advance Assessment:
For 510(k) advance evaluation of medical devices, FDA typically does not issue a "certificate" but rather a "license." In general, this type of permit does not have a fixed validity period. However, manufacturers are required to file a new 510(k) with the FDA when there is a significant change in the product, a change in technical standards, or a change in FDA regulations.
2. premarket approval（pma）：
For high-risk medical devices and certain drugs, PMA is often required. The approval of the PMA is permanent, but the holder is required to submit regular updates and reports to ensure the quality and safety of the product.
3.New Drug Marketing Approval:
For the marketing approval of new drugs, the FDA will issue a "New Drug Approval Notice". This is usually a permanent approval, but pharmaceutical companies need to comply with regulations, including regular reporting and following good manufacturing practices (GMPs).
4.Food Additive Approval:
Approval of food additives is usually long-lasting, but manufacturers need to ensure that their products and production processes are always FDA-compliant. FDA may conduct periodic inspections and audits of products.
5.Cosmetics Registration:
Cosmetics do not need to be approved by the FDA for pre-market approval, but manufacturers are required to register their products before they can be marketed. There is no fixed expiration date for cosmetic product registration, but manufacturers need to ensure that the product meets FDA labeling and ingredient requirements.
Overall, while many FDA certifications or approvals are permanent, manufacturers need to be ready to cooperate with FDA reviews and updates on an ongoing basis after obtaining certification. In addition, if there are significant changes to the product or if there is a change in regulations, the manufacturer may need to re-contact the FDA, submit the necessary documentation and obtain a new endorsement or approval. In all cases, it is the responsibility of the holder to maintain ongoing communication with the FDA and comply with regulations to ensure that the product is legally available for sale and use in the market.