Friday, July 13, 2018 10:56:10 PM
Biel met several times with the FDA during the original 510K submittal. In that submittal, the FDA reviewed Biel's Real World Data for Back pain, but finally, refused to accept the real world data and clear the Actipatch for knee and foot in February 3, 2017.
How Long it took for the first 510K?
Submittal: August 10, 2015
Approval: February 3, 2017
Number of Months: 17 Months
So. It took 17 months to approve the Actipatch for knee and foot and deny them approval for back pain, requiring a clinical trial.
Then, they denied them full body muscle and joint approval, requiring one more clinical trial on back pain. As you can see from this example, the length of time it takes is not as simple as waiting in line and your line comes and you are approved. It is much more complicated than that. Thus, the average time reported in the report you shared is almost meaningless, as it is skewed by more complicated cases. The 17 months that Biel took for approval can skew the data big time.
The 510K approval includes multi facet reviewes related to the product mechanism of action, safety, labeling, clinical data review, and many other details. Those other details are already reviewed by the FDA over 17 months period during the first approval.
Essentially, the FDA is familiar with the product and know that the product has no issues. All they care about for the upcoming approval is the back pain clinical trial. However, during the pre-submission approval meeting with the FDA on May 9,
the FDA had access to the data and a significant part of the discussion was focused on statistical analysis, as reported by the CEO.
In Summary, this application is expedited because of the circumstances and as expressed by Dr. Koneru after the FDA pre-submission approval meeting.
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