Special 510k Operating System for Data Management Software Design Documents

S

Silvertabb

#1
Hi,
when submitting a special 510k ffor new Operating Systems for data management software (stand alone used to retrieve data from Class II medical devices), is it required to include the following:
SW Architecture Document
SW Design Document
SW Development and Project Management Plan

Please provide Scenarios based on some assumption, if you believe you still need information to answer this question.

Thanks,
Silvertabb
 
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glork98

Involved In Discussions
#3
Please provide Scenarios based on some assumption, if you believe you still need information to answer this question.
I'd like to have more info before I invest my time.

What specific standards are you complying with?

What do your SOPs call for?

What class is the software you are creating?
 
G

George Weiss

#4
Your question: "what do I submit? "
Answer: It depends on the "Level of concern". (this is an FDA phrase, not mine)
It would be important to locate similar programs, (like yours), on the FDA site, which helps in the process.
It takes a bit of special searching, and there are then tables of similar PASSed applications. There is then full documentation of their submissions.
FDA: Software within medical device requirements @
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm089543.htm#8
A better FDA document @ page 12 has a table of requirements/level of concern
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM089593.pdf
happy hunting !
 
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