A Medical Device U.S. Freedom of Sale Certificate may be revoked or revoked in the following circumstances:
Failure to comply with regulatory requirements: FDA may take action to revoke or revoke a Free to Sell Certificate if the manufacturer or distributor fails to comply with FDA regulatory requirements or violates the law, such as failing to report adverse events for the device, failing to comply with regulatory requirements for the product**, etc.
Product quality issues: If a medical device causes a safety or quality issue in the marketplace, the FDA may conduct an investigation of the product and decide whether to revoke or revoke the free sale certificate based on the results of the investigation.
Insufficient or unqualified clinical data: If the clinical data provided by the manufacturer is insufficient or cannot demonstrate the safety and efficacy of the medical device, the FDA may review the free to sell certificate and may ultimately revoke or revoke the certificate.
Ongoing regulatory non-compliance: FDA regularly monitors medical devices, and if a manufacturer fails to meet ongoing regulatory requirements, fails to submit required reports, updates, or other regulatory requirements in a timely manner, FDA may take action to revoke or revoke a Free to Sell Certificate.
Product recalls: If a medical device is subject to a product recall due to safety or quality issues, the FDA may investigate the manufacturer and may ultimately revoke or revoke the Free to Sell Certificate.
In summary, a Medical Device Certificate of Free Sale may be revoked or revoked in the event of a serious violation of the manufacturer or product, safety issues, quality issues, or other serious issues. In such cases, FDA will take action to protect the health and safety of the public.