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.
For each difference you should determine an objective method for demonstrating that the difference is equivalent in safety and performance to the predicate. Your test method can be proposed to the FDA in a pre-sub request prior to testing. The FDA sees more than 3,000 companies propose testing methods to demonstrate equivalence each year. They have more experience than you do. Ask them in a pre-sub before you test anything.

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:
https://fdaecopy.com/nse-letter/.

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/.

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Earlier this year I recorded a webinar on the 4th edition of MEDDEV 2.7/1 for clinical evaluations, but the new European Medical Device Regulations requires additional changes to the clinical evaluation process. If you already have CE Marking, you have 3 years to gather the clinical data you need to meet the new requirements. If you don’t you will no longer be able to CE Mark your products–even for Class 1 devices.

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/.

source: https://www.linkedin.com/groups/2070960/2070960-6252711135179603972