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How does your design plan change when you are preparing a Special 510(k) instead of a Traditional 510(k)?
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Most 510(k) submissions are Traditional 510(k) submissions. However, once you already have 510(k) clearance for your device, you still need to obtain FDA clearance for significant changes to the device. Approximately 10% of the submissions are Special 510(k) submission types. These are minor modifications to the originally cleared device.
The huge advantage of a Special-type submission is that the FDA timeline for decision on your submission is 30 days instead of 90 days. However, you need to make sure that you are making a minor modification to the device. If there are multiple changes, and the changes require multiple functional specialties to review your submission, then your submission will be converted to a Traditional-type of submission and clearance will be delayed.
One strategy that has been used successfully is to submit a series of minor device modifications as a series of Special 510(k) submissions. This is especially useful for software feature additions.
However, most design processes and 510(k) templates that companies use are specific to Traditional-type 510(k) submissions. You need to modify your templates, your submission strategy and your overall design plan for a Special-type submission.
Next Thursday, March 8 @ 1pm EST, I will be hosting a webinar to show people how I modify 510(k) templates for a Special 510(k). I will also explain different strategies for Special 510(k) submissions. Finally, you will learn how to change your approach to design planning for these minor device modifications.
If you are interested in participating in the free webinar, please register on the following webpage: http://medicaldeviceacademy.com/special-510k-submission-webinar/.
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On Thursday, March 8, 2018 @ 1pm – 2pm (EST), Rob Packard is presenting a Special 510k Submission Webinar to explain how your design plan should be different for a Special 510k Submission.
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