Pharmaceutical consulting and generic drug professionals: On February 18, 2014, the final guidance document was released regarding FDA’s Pre-Submission programme, Requests for Feedback on Medical Device Submissions: The Pre-Submission Programme and Meetings with Food and Drug Administration Staff.
FDA’s Pre-submission programme was formerly known as the pre-IDE (Investigational Device Exemption) programme; however, it was expanded to other applications in 2014.
It now includes 510(k), PMAs, HDEs, CLIAs, and certain INDs.
So, you can garner formal feedback for your related submissions prior to submitting. You may even find out a submission or clinical study is not necessary. It could prove a worthwhile resource.