Pre-Sub Meeting


Hi all,

I'm new here. My company is developing a medical device and working towards our first ever 510k submission. I am currently drafting a Pre-Sub for the FDA to introduce ourselves. I've reviewed the guidance docs on the topic but was hoping for a little bit of insight on the following elements that I've put in bolded font...

1. Cover Letter
2. Table of Contents
3. Device description
3.1 Comparison to Predicate - Is there an appropriate/preferred way to format this? Is a table acceptable, or should it be written in paragraph form?
4. Proposed intended use/indications for use
5. A summary of any previous discussions or submissions
6. An overview of planned product development - I plan to include the general information for the proposed testing we will conduct (biocomp, EMC/electrical, human factors, etc.) However, we are using a CM for manufacturing. Are there any key details about product development on the manufacturing side that I should be sure to touch upon here- such as critical components testing, process validation, MSA? Any insight on key topics the FDA might want to see here is highly appreciated.

Thanks so much in advance.

Ed Panek

QA RA Small Med Dev Company
Super Moderator
#3 table format with a comparison between specifications claiming similarity or identicality to the other

you can go to the FDA 510(k) website and look for the 510(k) you are drawing equivalence with and copy a lot of the format.

FDA will not advise you directly what to do without a prompt from you first. Tell them what you want to do and if they agree with that pathway

A 510(k) isnt focused heavily on production. Its mostly about the safety and effictiveness data of the device itself. Human Factors too. Once its cleared and you begin production and sales you will start to receive complaints. In about 12-24 months the FDA will audit you possibly onsite depending on the risk. At that point production, CAPA, Training, and complaint trending will be looked at. 21 CFR 820.30 will also be reviewed to ensure you are staying compliant.


Trusted Information Resource
Regarding comparison to predicate, the most common approach is a table. And, of course, it would be nice to add some paragraph with some further information.

Regarding planned product development, I would limit the information on CM to a minimum unless it is essential for the specific questions for FDA.


Swimming In The Soup

Involved In Discussions
They won't help you much without specific targeted questions. The questions should be in this format:

Is the predicate comparison in the correct format for 510(k) submission?

Does FDA identify any issues with the indications for use?

Are there any gaps identified by FDA in the safety testing plan?

The Pre-sub is geared for the FDA to answer questions regarding the 510(K) submission ideally to prevent you from spending the money to have it rejected. It also saves the agency time in the evaluation process.

Hope this helps.


Thanks everyone. In terms of outlined testing, I plan on listing each test that we are planning to do along with the referenced standard for each individual test. Is this acceptable in a table format or in paragraph form?

Ed Panek

QA RA Small Med Dev Company
Super Moderator
Assuming this is a Class II device for reasons of performance specification make sure you test to the FDA's harmonized standard. If you must, explain any deviations from the standard and why it is okay to justify S&E
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