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The time frame for FDA certification of medical devices in the U.S. depends on the type of device and the regulatory pathway required. Here’s a breakdown:

1. Premarket Approval (PMA) (for Class III devices):

   • Standard Review: The FDA aims to review a PMA application within 180 days, but the process often takes longer due to the complexity of the device and the need for clinical trials. The total approval time can range from 1 to 3 years.
   • Priority Review: In some cases, if the device meets specific criteria (e.g., addressing an unmet medical need), the FDA may grant a priority review, which can shorten the timeline to 6-12 months.

2. 510(k) Premarket Notification (for Class II devices):

   • The typical review time for a 510(k) submission is around 3 to 6 months, though it can take longer if additional information or testing is required. In some cases, the process may be completed in as little as 90 days.

3. De Novo Classification Request (for novel devices that are not substantially equivalent to any existing devices):

   • The review time for a De Novo request is usually around 6 months, but it can vary depending on the device and the amount of data needed for evaluation.

4. Breakthrough Device Program:

   • For devices designated under the FDA’s Breakthrough Device Program, the FDA works more closely with manufacturers to expedite the review process. The timeline can vary but is generally faster than the standard PMA or 510(k) process.

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