The approval time for FDA registration and certification in the USA varies widely depending on the type of medical device and the regulatory pathway it follows. The two main pathways are the 510(k) premarket notification and the Premarket Approval (PMA) process.

1. 510(k) Premarket Notification:The 510(k) process is for devices that are substantially equivalent to existing devices on the market. The FDA aims to complete its review within 90 days of receiving a complete submission. However, the overall process, including preparation, submission, and any additional interactions with the FDA, can take between 3 to 6 months. Delays can occur if the submission is incomplete or if the FDA requests additional information or data. For devices that are more complex or that raise new questions, the review may extend beyond 90 days.

2. Premarket Approval (PMA):The PMA process is required for higher-risk devices that typically need extensive clinical data to demonstrate safety and effectiveness. The FDA’s goal for reviewing a PMA application is up to 180 days. However, the actual time from submission to approval can be significantly longer. The process often involves extensive clinical trials, which can take several years, and the FDA may request additional data or revisions. Consequently, the entire PMA process can take from 1 to 2 years or more, depending on the complexity of the device, the quality of the submitted data, and the need for further information.

In summary, while the FDA has set target timelines for reviewing submissions—90 days for 510(k) and 180 days for PMA—the actual time to receive FDA approval can be influenced by the device’s complexity, submission quality, and any additional requirements or interactions needed throughout the review process.

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