< 1 min reading time Hello everyone, For one of my design classes for medical devices we have to go through all forms of an FDA submission. One of the requirements was design inputs and outputs, I was curious is there a certain format that this should be written in and how detailed should they be, I couldn’t find any examples online. Your input will be very helpful. source: https://www.linkedin.com/groups/78665/78665-6056828884710678530 Marked as spam |
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Private answer Karen Boyd, ASQ CQA Jeff, did you begin or locate FDA's Design Control Guidance document? If not, here is a link - http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm070642.pdf. Marked as spam | |
Private answer Jeff Schreiber Yes I did happen to see that, I guess my question is are there any examples of these forms out there, or perhaps maybe a fill in sheet. I would like to make my forms look professional and up to FDA standards. Marked as spam | |
Private answer Karen Boyd, ASQ CQA Based on the recommendations in that FDA guideline, FDA submission requirements, and any customer, product, or design class requirements, you could create a basic matrix or Excel chart to organize the information [including each design characteristic / function / requirement, then input for each, output for each, acceptance criteria - how output meets input, and verification / validation evidence - drawing, spec, test result, etc.]. Marked as spam | |
Private answer Julie Omohundro There is no required format, but they are typically in the type of Excel format Karen refers to. I can send you a template. My email address is in my LinkedIn profile under the Contact Info tab. Marked as spam | |
Private answer Jeff Schreiber Yes that would be very helpful Julie. I am not seeing your contact info on your page. I will message you my email address instead. Thank you!! Marked as spam | |
Private answer Julie Omohundro It's tucked away where no one can find it. So LinkedIn. :) Marked as spam | |
Private answer Daniel Feller Jeff, did anyone pass along examples of requirement decomposition and expression? If you still need some examples I can email to you. Marked as spam | |
Private answer Jeff Schreiber Hey Daniel, Julie said she would send me a template but I definitely will take more examples if you are able to send them, it will give me a better understanding of what the FDA expects. My email address is on my LinkedIn page. Thank you everyone for your input. Marked as spam | |
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