3 Humorous Reasons Medical Device FDA Submissions could be Rejected

Do it Right or do it over and over and over again…

If you look around the Internet, you’ll see a ton of good-to-great Medical Device FDA Submittal advice – and it’s certainly worth your while to go through the information. Especially if it’s your first submittal.

We wanted to share a few gems that caused serious delays (push backs) from the FDA.

Before I dive in, a quick note: be sure to reference the Refuse to Accept (RTA) checklist. It literally is a checklist of what needs to be included and it’s a great place to start.

Also, when entering data into the submittal form make sure not to put N/A on anything. If something doesn’t apply (for whatever reason) be sure to provide a solid explanation why that section doesn’t apply to your device.

OK, here we go!

  1. The biggest challenge we’ve seen is when teams are new to submittals and they aren’t fully aware of the process. For example, if you don’t provide complete test evidence for all requirements, specifications, and hazards, (and you only enter test summaries) it will be a guaranteed rejection. You need to include the full protocols and reports.  Let’s put it this way; if the FDA gets the feeling that you don’t know what you’re doing – by virtue of your incomplete submission – they’re going to bury you in additional requests for more information. This is known as the No Fun Zone.
  2. The second problem is simple but extremely important – when it appears you don’t know the difference between verification and validation. We’ve seen them combined in a single test report and the FDA response was like – WTH? I remind you, dear reader, that we all have gone through this process for the first time ourselves…during our careers…and we’ve made these mistakes too.  We want you to benefit from our faux pas’…not repeat them 😊

A humorous side note; when I first performed SQE work in the Medtech Industry I was asked to find out whether IQ/OQ/PQ validation had been performed on a particular project and by whom.

The request sounded like Lions & Tigers and Bears, oh my!

I was too embarrassed to ask what the heck it was so I googled it. Thank gawd for the Internet…

{IQ = installation qualification, OQ = operational qualification, PQ = performance qualification, job of QA}

     3. Last but not least – if you fail to answer previous FDA requests for information on your submission. That’s a killer because it gives the impression you’re trying to ignore something.

It’s naughty behavior that will be scolded.

As I stated in item 1 above – make sure to provide a complete and valid, submission, and by all means, work with people who’ve done this (successfully) before.  It’s worth investing in an experienced resource, in order to complete the submission in your lifetime and keep you in good graces with the FDA.  They really do want to help…but in a collaborative way.  Remember – Medical Devices could do damage to people, and the FDA wants to prevent that from occurring.

There’s more that I could add…but this is a good start.

I hope this has been helpful and that you’ve been able to learn something, while having a little fun.

If you’d like more information regarding the FDA submittal process please feel free to reach out to us – we’re here to help.


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