...the more you learn...the more you will want us for FDA!
photo of a 510 (K)
This photo depicts a typical submission for a Class II, computer driven medical device with proprietary software. This application is currently before the Center for Devives and Radiological Health. It is under going a round of questions for additional information, as of September 2001. This includes the three original volumes submitted and one volume necessary to respond to the questions. Recently CD's are allowed. There is a tradeoff between the paper and CD's. We will advise you.
copyright by Compliance Consultants, Stamford, CT USA, September 2001
Compliance Consultants