Pharma consultants: Did you know there is a medical device programme that is beneficial to some aspects of drug applications?
FDA’s Pre-submission programme was formerly known as the pre-IDE (Investigational Device Exemption) program, however it was expanded to other applications in 2014.
It now includes 510(k), PMAs, HDEs, CLIAs, and certain INDs. It is a beneficial tool, that is commonly overlooked by medical device experts, and even more so by pharma experts, partly due to its name.
The final guidance document is named Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff.