Is a Quality Manual part of a 510k Submission?


Involved In Discussions
I've been informed that part of our 510k submission is our quality manual. Given that over half of the information in the manual does not apply to the submission (there are no submission details on operations, manufacturing, service, purchasing, etc.), I would think that the quality processes that apply to the submission would be the only things to submit. It seems to me that giving more information just delays the analysis of the submission and opens the door for extra questions. What's the common/accepted practice for including the quality manual or "extra" processes not related to the requested submission pieces?

Thank you.
S. Schoepel


Hello SSchoeppel,

You don't have to submit your Quality Manual when you apply for a 510k submission. For more information on what needs to be included in a 510k submission, you may want to check out the Device Advice section of the CDRH website, the general guidance documents related to 510(k) submissions, and any specific guidance document that the FDA may have published with regard to your device.
Top Bottom