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Performance Goals For The Medical Device User Fee And Modernization Act Of 2002 -- (Senate - November 19, 2002)

The FDA outlined their performance goals for implementation of the User Fees being imposed as of October 1, 2002. Basically the goals were to speed up the review time of the PMA and 510(k) submissions.

“These goals represent a realistic projection of what the Food and Drug Administration's Center for Devices and Radiological Health and Center for Biologics Evaluation and Research can accomplish with industry cooperation,” as stated by Secretary of the Health and Human Services.

The following is a review of these goals for the coming years:

A. ORIGINAL PREMARKET APPROVAL (PMA), PANEL-PMATRACK SUPPLEMENT, AND PREMARKET REPORT SUBMISSIONS

1. The following cycle goals apply to: 75% of submission received in fiscal year 2005; 80% of submissions received in fiscal year 2006; 90% of submissions received in fiscal year 2007.

   (a) First action major deficiency letters will issue within 150 days.

   (b) All other first action letters (approval, approvable, approvable pending good manufacturing practices (GMP) inspection, not approvable, or denial) will issue within 180 days.

   (c) Second or later action major deficiency letters will issue within 120 days.

   (d) Amendments containing a complete response to major deficiency or not approvable letters will be acted on within 180 days.

2. Decision Goals:

   (a) 80% of submissions received in fiscal year 2006 will have an FDA decision in 320 days.

   (b) 90% of submissions received in fiscal year 2007 will have an FDA decision in 320 days.

1. Subject to the following paragraph, 50% of submissions received in fiscal year 2007 will have an FDA decision in 180 days.

This goal will be re-evaluated following the end of fiscal year 2005. FDA will hold a public meeting to consult with its stakeholders and to determine whether this goal is appropriate for implementation in fiscal year 2007. If FDA determines that the goal is not appropriate, prior to August 1, 2006, the Secretary will send a letter to the Committee on Health, Education, Labor and pensions of the Senate and to the Energy and Commerce Committee, Subcommittee on Health of the House of Representatives stating that the goal will not be implemented and the rationale for its removal.

2. 90% of amendments containing a complete response to an approvable letter received in fiscal years 2003 through 2007 will be acted on within 30 days.

There were also goals for Expedited PMA decisions as well as 180-day submissions.

For 510(k)s the following were the defined goals:

1. The following goals apply to: 70% of submissions received in fiscal year 2005; 80% of submissions received in fiscal year 2006; 90% of submissions received in fiscal year 2007.
      (a) First action additional information letters will issue within 75 days.
      (b) Subsequent action letters will issue within 60 days.
2. Decision Goals:
      (a) 75% of submissions received in fiscal years 2005 and 2006 will have an FDA decision in 90 days.
3. 3. Subject to the following paragraph, 80% of submissions received in fiscal year 2007 will have an FDA decision in 90 days.

This goal will be re-evaluated following the end of fiscal year 2005. FDA will hold a public meeting to consult with its stakeholders and to determine whether this goal is appropriate for implementation in fiscal year 2007. If FDA determines that the goal is not appropriate, prior to August 1, 2006, the Secretary will send a letter to the Committee on Health, Education, Labor and Pensions of the Senate and to the Energy and Commerce Committee, Subcommittee on Health of the House of Representatives stating that the goal will not be implemented and the rationale for its removal, and that the goal for fiscal year 2006 will be implemented for fiscal year 2007.

There was also goals for BLAs.

As you can see these goals will not go into effect for more than two years. Will this User Fee be worth the few extra days possible saved (the FDA cannot guarantee that all submissions will be reviewed in the 75 day time frame for 510(k)s even after paying into this system for four years?

For a copy of statement go to http://www.fda.gov/cdrh/mdufma/pgoals.html

For any questions please contact mdi at Userfee@mdiconsultants.com

U.S. AGENT SECTION

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