How long it take FDA medical device approval process?
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Please let me know what is FDA medical device approval process? and How long it takes for FDA approval process. Thank in advance.
The time taken very much depends on the type of device and whether or not it is subject to the 510K process or the PMA process. Refer to the FDA website for information on both processes.
The time taken will also depend on whether or not the FDA come back with any questions once the initial documentation has been submitted. If the FDA have any questions on the submission the time clock on the review process stops until the answers have been submitted.
The approval process depends on the level of information shared and the device class. Basically, the timeline is fixed, however, the approval process varies based on the following items;
1. Studies conducted to justify the claim
2. Gaps/ insufficient data in the technical file
3. Intended use variation
4. Different predicate device
5. Repeatability of the safety studies
6. Identifying the right standard
7. Sterilization issues
8. Noncompliance to the regulatory requirement
9. Following the different route to reach into the market
10. Medical Device classification
11. Non-justification of sample size
So, the manufacturer needs to accumulate the information for a similar type of device for any variation or suggestion provided by the regulators, to avoid misapprehend and impede in the approval process.