Reputation of a contact person with FDA while corresponding for 510k

J

Jennifer27

#1
Hi All!!
Hope u all are doing great:)

Ours is a moderate level of concern software device. No clinical data involved.

My company wants to write my name as the contact person in the 510k application and they want me to correspond with the FDA on their behalf. However, I have not prepared all the content of the 510k application, hence I'm not too sure about its accuracy.

I want to know that if there are certain shortcomings that FDA explores in our application and gets back to me or in the worst case the 510k submission gets rejected. Will it harm my career?

I mean will it come in records of the FDA that FDA had a negative communication with this particular person (the contact person on the 510k) and in the future if there is any other application submitted by the this particular person then they will look at it with doubt. :(

I don't know, I'm not sure if I should request my employer not to write my name there.

Please help!!
 
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Stijloor

Staff member
Super Moderator
#2
Hi All!!
Hope u all are doing great:)

Ours is a moderate level of concern software device. No clinical data involved.

My company wants to write my name as the contact person in the 510k application and they want me to correspond with the FDA on their behalf. However, I have not prepared all the content of the 510k application, hence I'm not too sure about its accuracy.

I want to know that if there are certain shortcomings that FDA explores in our application and gets back to me or in the worst case the 510k submission gets rejected. Will it harm my career?

I mean will it come in records of the FDA that FDA had a negative communication with this particular person (the contact person on the 510k) and in the future if there is any other application submitted by the this particular person then they will look at it with doubt. :(

I don't know, I'm not sure if I should request my employer not to write my name there.

Please help!!
Can someone help Jennifer?

Thank you!!

Stijloor.
 
T

The Specialist

#3
Hi All!!
Hope u all are doing great:)

Ours is a moderate level of concern software device. No clinical data involved.

My company wants to write my name as the contact person in the 510k application and they want me to correspond with the FDA on their behalf. However, I have not prepared all the content of the 510k application, hence I'm not too sure about its accuracy.

I want to know that if there are certain shortcomings that FDA explores in our application and gets back to me or in the worst case the 510k submission gets rejected. Will it harm my career?

I mean will it come in records of the FDA that FDA had a negative communication with this particular person (the contact person on the 510k) and in the future if there is any other application submitted by the this particular person then they will look at it with doubt. :(

I don't know, I'm not sure if I should request my employer not to write my name there.

Please help!!

Whilst I am no authority on this, I would think it unlikely that a professional body would keep such records.

The FDA will identify any shortcomings in the 510k application and will inform you, in order that you take corrective action.

I am surprised that your company wishes to put you forward if you are unsure about the 510k content though...
Perhaps you should familiarise yourself with the data contained within the 510k application.

In my opinion, your career will be more likely boosted by this level of involvement and new experience, rather than dented.

Take this opportunity to gain new experiences and reach new heights in your career. It'll be good for your CV.
 
M

MIREGMGR

#4
I don't think the FDA tracks individuals.

I'm under the impression that they do track certain types of voluntary-inquiry contacts from companies, though. When you call DSMICA and provide company identification, it's apparent that they're logging that information. I've gotten the impression that our district's office, at least, also logs such info on informal contacts.

I have a theory that the FDA operates a scoring system as a factor in de-prioritizing companies for other-than-for-cause inspections, and each contact with the FDA (not counting formal actions such as 510[k] filings) that's of a nature indicating that a given company is actively engaged in applying the rules and trying to do the right thing is entered into that scoring system.

I 100% agree that if your name will be on the 510(k), you should be an expert in its substance. If the examiner has a question about it, he or she will call the contact person. If the contact person doesn't know the answers the examiner needs, the examiner will be (polite word is "displeased"), which is always a very bad idea from the applicant's perspective.
 
Last edited by a moderator:

Ronen E

Problem Solver
Staff member
Moderator
#5
I 100% agree that if your name will be on the 510(k), you should be an expert in its substance. If the examiner has a question about it, he or she will call the contact person. If the contact person doesn't know the answers the examiner needs, the examiner will be (polite word is "displeased"), which is always a very bad idea from the applicant's perspective.
While I generally agree, I think things should be put in the right proportion. It's true that the contact person should be familiar with the submission content and the subject matter in general, but I don't think anybody really expects them to be an expert on every detail. Typically, the contact person can be someone from QA or RA department, and obviously such a person will almost never master the device design (for instance) to the last subtlety, like the designer or the R&D engineer.

I think a more realistic approach would be to have a contact person that *either* addresses any queries based on their own knowledge (also being able to judge whether their knowledge is sufficient to do that), *or* conveys them to the specialist(s) in house; follows up to get the best response; then relays back to the FDA; all the above in a timely and reliable manner.
 

Statistical Steven

Statistician
Staff member
Super Moderator
#6
When I first read the post I thought you were being sarcastic. Sorry for my insensitivity. In no way does having your name on a 510(k) impact your career either positively or negatively. You can be an optimist whereby a flawless 510(k) would be a positive for your career. Each application is reviewed on its merits. No single person within an organization knows everyhting in the application, but you are the project leader that knows who to go to with a question.
 
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