五月天堂婷婷爱,色狠狠天天综合色香阁,91免费看国产,久久久久成人精品亚洲国产av综合,91啦在线播放,免费a一级毛片在线播放,天天日日夜夜看综合网,亚洲成人国产精品,奇米影视7777狠狠狠狠色,日韩精品高清在线观看,福利久久久,久久99国产精品片久久99蜜桃,91香蕉视频网址,婷婷91,久久久久久臀欲欧美日韩,少妇丰满大乳被男人揉捏视频

How many days does it take to obtain FDA certification in the USA?
Category：行業(yè)資訊 Date：2024-08-28 16:55:27 Author: Source:
In summary, while the FDA aims to review 510(k) submissions within 90 days and PMA submissions within 180 days, the actual time to obtain FDA certification can be influenced by various factors and may extend beyond these timeframes.

The time required to obtain FDA certification in the USA can vary significantly depending on the type of medical device and the specific regulatory pathway it follows. Generally, there are two primary pathways for FDA certification: the 510(k) premarket notification and the Premarket Approval (PMA) process.7(2).jpg

  1. 510(k) Premarket Notification:The 510(k) process is used for devices that are substantially equivalent to an already legally marketed device. The FDA's goal for reviewing a 510(k) submission is 90 days. However, the actual time can be longer depending on several factors:

    • Completeness of Submission: If the submission is incomplete or if the FDA requests additional information, the process can be extended.
    • Device Complexity: More complex devices may require additional time for review.
    • FDA Workload: High submission volumes can affect review times.

    On average, the entire 510(k) process, including preparation, submission, and review, can take between 3 to 6 months. In some cases, it might be longer if there are issues or additional information is needed.

  2. Premarket Approval (PMA):The PMA process is used for higher-risk devices that require more extensive clinical data. The review time for a PMA submission is generally up to 180 days, but the total time can be much longer. Factors influencing the PMA timeline include:

    • Clinical Trials: If clinical trials are needed, this can extend the timeline significantly.
    • Complexity of Device: More complex devices with novel technologies can require more time for evaluation.
    • FDA Feedback: The need for additional data or revisions can lengthen the review process.

    Overall, the PMA process can take anywhere from 1 to 2 years or more, depending on the specifics of the submission and the review process.

In summary, while the FDA aims to review 510(k) submissions within 90 days and PMA submissions within 180 days, the actual time to obtain FDA certification can be influenced by various factors and may extend beyond these timeframes.

Contact Us：

Whatsapp or Wechat：+86 15816864648；email address：hito.lin@grzan.cn