Design Inputs - Final Medical Device Specifications

Mandy

Involved In Discussions
#1
The Design Input section of the Medical Device Quality Systems Manual: A Small Entity Compliance Guide mentions the need to have a final device specification which covers all the device characteristics.

Our company does not have such a document, since our DHF and DMR include all the pertinent information, for example including a very detailed Design Input document.

I just wanted to ask you regulatory experts out there whether this is sufficient for an FDA inspector.

Thanks
Mandy
 
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yodon

Staff member
Super Moderator
#2
I see most of the right things in your post but I don't see that you've addressed what your device is supposed to do (i.e., functional requirements). If that's what you include in your Design Inputs (and you have a mapping to how you verified them) I would think you'd be in good shape. Without actually seeing what you have (and I'm not suggesting you post it) and without knowing your product (and regulatory class), it's hard to say whether it would be considered acceptable.

P.S. It appears the guide you referenced was withdrawn in Dec '13.
 

Mandy

Involved In Discussions
#3
We do have detailed functional requirements, and we do Design Verification of these requirements, so I think we are covered.

Thanks for your response.

Have a great day,
Mandy:thanx:
 

Mandy

Involved In Discussions
#5
Ronen, I refer you to CFR 820.181 on Device Master Records. Paragraph (a) talks about a device specification. I was under the impression (from the Medical Device Quality Systems Manual: A Small Entity Compliance Guide which I know has been recalled, but is still a wealth of information) that we needed a separate document.

However, as you write we have detailed D. Output plus the DMR and DHF therefore I think we are covered.

Kol tuv, :cool:
Mandy
 
O

Oscar Wang

#6
Design input contains two parts, intended use and final MD specifications. FDA will inspect not only whether your DM specification is fully verified but also check whether intended use needs are fullfilled. a full set of spec<->verification and user needs<-> validation DHF shall be ready for facility inspection. If there is not an index file for all product specifications, how do you justify that a specific requirement is applicable for your device? You will also have problem when you want to do a Engineering change.
 
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