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How long is the estimated time to process FDA registration and certification in the USA?
Category：行業(yè)資訊 Date：2024-08-28 16:56:43 Author: Source:
In summary, the time required for FDA registration and certification depends on the device type and the regulatory pathway. For a 510(k) submission, the process typically takes 3 to 6 months, while a PMA can extend from 1 to 2 years or more. The exact timeframe can be influenced by factors such as the complexity of the device, the completeness of the submission, and any additional requests from the FDA.

The estimated time to process FDA registration and certification in the USA can vary significantly depending on the type of medical device and the regulatory pathway used. The two primary pathways are the 510(k) premarket notification and the Premarket Approval (PMA) process.7(1).jpg

  1. 510(k) Premarket Notification:The 510(k) pathway is for devices that are substantially equivalent to existing, legally marketed devices. The FDA aims to complete its review within 90 days of receiving a complete application. However, the overall time from submission to receiving approval can range from 3 to 6 months. This includes not only the FDA’s review period but also the time spent preparing the application, responding to any additional information requests from the FDA, and addressing any potential issues or deficiencies identified during the review process. Complex devices or those requiring additional data may experience longer review times.

  2. Premarket Approval (PMA):The PMA process is used for higher-risk devices that require comprehensive clinical data to demonstrate safety and effectiveness. The FDA targets a review time of up to 180 days for PMA applications. Nevertheless, the entire process can take 1 to 2 years or more. This extended timeframe accounts for the preparation of extensive clinical trials, the collection of supporting data, and the time needed for the FDA to review the data and potentially request further information or modifications. The PMA process is more involved and can be extended if additional studies or information are required.

In summary, the time required for FDA registration and certification depends on the device type and the regulatory pathway. For a 510(k) submission, the process typically takes 3 to 6 months, while a PMA can extend from 1 to 2 years or more. The exact timeframe can be influenced by factors such as the complexity of the device, the completeness of the submission, and any additional requests from the FDA.

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