Hello to everybody,

All of you know that 510K submissions are accepted from the manufacturer, Specification developer, etc.

what are all the details to be submitted to fda for 510K approval ( class II) by a specification developer?

Regards,
Raghu

510(k)s are submitted for introducing a medical device into the US market. See:

http://www.fda.gov/cdrh/devadvice/314.html

I don't think the submittal details differ - you still have to show the device was developed and manufactured in accordance with the QSR. It's just a matter of whose name is on the submission (and who is responsible for meeting the requirements).

We're supporting a similar situation. The "specification developer" is the submitter. They contract with us to do all the hw & sw design and they contract with another company for manufacturing. We will be expected to collect all records relating to the design work. Similarly, the manufacturer will collect all records related to manufacturing. The contractor will be expected to show that the whole process is compliant with the QSR.

Does that help?