Hi Experts,
My company is planning to submit a special 510(k) - a modification to our own device. However, the modification is material change of patient contacting part of the device. Since, I think NO DATA can be submitted as a part of a Special 510(k) I am thinking we should do a traditional 510(k). Because for patient contacting material change FDA might want to see Biocompatibility report and since DATA cannot be submitted in a Special 510(k), FDA might convert the Special 510(k) to a Traditional 510(k). Please let me know what you think -
Can we submit data with a special 510(k)? Is there any guidance document which clarifies this?
For a patient contacting material change, would FDA want to see biocompatibility test data?
I look forward to hear from you,