MDUFA III Fees

The fees for 2013 are as follows (small-business fees in parentheses):

Featured Products
PMAs:	$248,000 ($62,000)
Panel-track PMA supplements:	$186,000 ($46,500)
180-day supplements:	$37,200 ($9,300)
Real-time supplements:	$17,360 ($4,340)
510(k):	$4,960 ($2,480)
30-day notice:	$3,968 ($1,984)
Request for classification:	$3,348 ($1,674)
3PMA annual report:	$8,680 ($2,170)
Annual establishment registration fee:	$2,575 ($2,575)

Featured Products

ComplianceOnline Training on Drugs Regulatory Requirements

Best Practices for Maintaining an IND and IDE Application with FDA
IND and IDE annual reports - Amending clinical protocols and informed consent – Format, Content, Editing, Submission of Documents

IDE (Investigational Device Exemption) for PMA and 510(k) for CDRH and CBER
Meetings with FDA - Sample Size Considerations - Inclusion/Exclusion Criteria - End Points - Case Report Forms - Administrative Plan

The IDE (Investigational Device Exemption) - It's Purpose and Preparation
The purpose of the IDE – FDA Expectations – preparation – recommended subject headings – content submission - follow up Usage in the clinical trial

Planning for a Successful Pre-IDE Meeting with FDA
Pre-IDE Meeting – Process- Submission preparation - presentation