What things go in Design Control Documentation for a 510k of Class II Medical Device

J

Jennifer27

#1
Hi all!
I'm preparing a Design Control document for 510k of a Class II software with moderate level of concern. I want to know

What all things will go in the design control for 510k submission
As per my understanding I should put in:
1. Design and Development Plan
2. Design Description (Including Design Input, change, control, transfer and output)
3. As summary of the source code and my entire source code
4. Traceability analysis and related documents
Please let me know if I should add or delete anything.

Also do we need to submit our Device Master Record and Design History File to the FDA?

I look forward to your input
Thanks so much
Jennifer
 
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jkuil

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J

Jennifer27

#3
Re: What things go in the Design Control Documentation for a 510k of class ii medical

Thanks Jan. I know these links but was just not sure whether I should submit DHF and DMF to FDA in the 510k submission or not?
 

Ronen E

Problem Solver
Staff member
Moderator
#4
Re: What things go in the Design Control Documentation for a 510k of class ii medical

Thanks Jan. I know these links but was just not sure whether I should submit DHF and DMF to FDA in the 510k submission or not?
Hi,

I wouldn't submit the DHF as a whole in a 510k submission. I'm not sure what you refer to as "DMF" but if it is the same as DMR (Device Master Record) then the same applies. The guidance is pretty focused in most cases; don't read too much into it. If something is missing in your submission, they'll let you know; you don't "lose points" if you have it ready and provide it at first request.

Cheers,
Ronen.
 
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