Abbreviated 510k for your submission or a traditional 510(k)?
Article explains how to decide if you can use an abbreviated 510k submission to save 30 days of review time instead of a 90-day traditional 510(k).
Last month (i.e., January 2017), there were only 9 abbreviated 510k submissions out of 222 510(k) submissions. The advantage of submitting an abbreviated 510k is that the FDA target for making a substantial equivalence decision is 60 days instead of 90 days. Why aren’t more company’s choosing the shorter pathway to 510(k) clearance?
What is a Special 510(k)?
Special 510(k) submissions are limited to minor device modifications. Therefore, any new device submissions are not eligible. In addition, in order for the FDA to review the submission in 30 days the device modifications must be limited to just one functional area (e.g., Section 15 or 16, but not both).
What is an Abbreviated 510k?
An abbreviated 510k submission is only permitted if:
- a guidance documents exists,
- a special control has been established, or
- FDA has recognized a relevant consensus standard.
Typically, each of the above scenarios is obvious if you review the product classification record for your device and you do not see any of the above listed under your product classification.
What is a Traditional 510(k)?
Traditional 510(k) submissions are required for the balance of 510(k) submissions. If you attempt to submit a special 510(k) or an abbreviated 510(k) when your submission is not eligible for these types, the FDA will inform you that your submission is being converted to a traditional type of submission. In addition, more detailed information may be requested by the FDA to comply with the submission requirements for a traditional 510(k).
How can you verify if your device is eligible for an abbreviated 510k?
The 510(k) premarket notification database allows you to search by submission type. If you select abbreviated 510k as the type from the pull-down menu, there are more than 500 in the database since 2011. You can limit this further by entering your 3-letter product classification code. If there are no records, then your device is not eligible. If you are unsure of your product classification code, or there are multiple codes, you can also limit your search by the panel responsible for the review. The only panel that has not accepted any abbreviated 510k submission is the Molecular Genetics panel (only 2 submissions have ever been cleared by that panel thus far).
How to learn more
If you want to learn more about abbreviated 510k submissions, here is a link for a blog on the topic. If you want to learn more about 510(k) submissions in general, I will be hosting a live, one-day 510(k) workshop in San Francisco on March 8, 2017.
FDA eCopy Checklist
Subscribe to download our checklist.