FDA Guidances on Device User Fees, MDUFA IV Goals & Pre-Submissions

The FDA has issued new  guidances for  medical device makers :

User Fee Guidances:

User Fees and Refunds for Premarket Notification Submissions (510(k)s)

User Fees and Refunds for Premarket Approval Applications and Device Biologics License Applications

User Fees and Refunds for De Novo Classification Requests

User Fees for 513(g) Requests for Information

Action Guidances:

FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals

FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals

FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals

Pre-Submission Program:

Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff