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If you receive an NSE letter from the FDA, you have four options for correcting the problems and resubmitting your device to the FDA. However, you want to avoid receiving a second NSE letter for the same FDA.
There are four causes for receiving an NSE letter. The first cause is: you failed to verify that the predicate is a legally marketed device. If your predicate was not registered and listed with the FDA (check using this link), then you should have submitted a pre-sub request to determine if the agency has any problem with using the device you chose as a predicate. This is an important question if the manufacturer is no longer in business and the product is no longer for sale.
The second cause is: you failed to evaluate the substantial equivalence of your device’s intended use with the predicate. The FDA typically will work with the company to modify the wording of FDA Form 3881 to ensure the intended use is equivalent or to make sure you provide clinical evidence to address the differences. In my pre-submission requests, I include a comparison document for the intended use to ensure that the FDA is aware of any differences in the intended use.
The third cause is: you failed to convince the FDA that technological differences do not raise different questions of safety and effectiveness. For each difference you must provide a justification for why the difference does not raise different issues or you must provide data to prove it. It is also possible that you were not aware of questions of safety and performance raised by technological differences. To avoid this problem you can submit a detailed device description and draft labeling to the FDA in a pre-sub meeting request.
The fourth cause is: you failed to provide data demonstrating equivalence.
In all four root causes identified above, you could benefit greatly from pre-sub meeting. The correction to your NSE letter may not be clear. You should consider requesting a pre-sub meeting as quickly as you can. Most companies choose not to submit a pre-sub meeting request, because they don’t want to wait 75-90 days. However, sometimes pre-sub meetings are scheduled sooner. In addition, 75-90 days is not as costly as receiving a second NSE letter.
If you want to learn more, read the complete article:
If you need help with your 510(k) submission, consider attending the 510(k) training workshop in Chicago on April 18: http://medicaldeviceacademy.com/chicago-510k-workshop/.
If your device is not on the market yet, you need to understand how the new regulations Affect your strategic marketing plan. The EU is no longer the market where medical devices are launched first. Clinical study data is now required for all CE Marked devices. You need clinical data. Learn how to obtain that data from your US customers on May 1st at the CE Marking Workshop in San Diego at 10x: http://medicaldeviceevents.com/.
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Anil Bhalani There is one more option. It sound a lot better in my language and is also humorous too. The literal translation is "Drown yourself in a bucket of water". You should have seen that NSE coming and withdrawn the 510(k). An NSE Letter is a letter of rejection. It also makes your 510(k) s public under FOI.
There is no second NSE like Robert says. One NSE terminates the 510(k) application.
The best option when you learn from the reviewer that you are receiving an NSE is to withdraw your 510(k) and refile a 510(k), a PMA or DeNovo 510(k). Or ditch the project. Before refiling, it is best to file a Pre-submission and discuss your options with the FDA.
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