US MDUFA Changes Signed into Law (Finally)

(Update: The following blog entry was revised on July 23, 2012 to reflect the most recent fee schedule in place at the FDA.)

The Medical Device User Fee Amendments of 2012 (MDUFA III) providing increased funding for the US Food  and Drug Administration have been signed into law as part of the FDA Safety and Innovation Act (FDASIA) by President Obama following months of intense negotiations between medical device industry and regulatory representatives.

MDUFA III establishes new performance goals and sets user fees to be paid by medical device manufacturers to the FDA for device registrations and listings. According to the FDA, the additional funding will allow for:

  • Hiring more than 200 additional FDA staff members
  • Amending the clinical trial approval process
  • Developing a new de novo pathway for risk-based device classifications
  • Expanding post-market surveillance
  • Reducing timelines


MDUFA III provisions go into effect October 1, 2012. User fees for 2013 are:

 

Function

Standard Fee

Small-business Fee

Pre-market Approval (PMA)

$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

PMA Annual Report

$8,680 

$2,170

Establishment Registration Fee

$2,575 

$2,575 

 

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