FDA encourages medical device manufacturers to obtain further guidanceprior to the submission of an IDE application. This will be especially beneficial to new sponsors who have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for existing technologies. Early interaction with the agency should help to increase the sponsor's understanding of FDA requirements, regulations, and guidance documents, and will allow FDA personnel to familiarize themselves with the new technologies.

Our qualified team of experts will successfully prepare and submit FDA medical device regulatory well reserched documentation to support your application. We will also help to schedule a meeting to help you get answers to all your questions on medical device development.

 To learn more about Pre-IDE process contact us today