Medical Devices

Agenda and Materials From January 28, 2009 FDA Performance Report

Agenda for Quarterly Meeting on MDUFMA / MDUFA Performance
9:00 – 11:00, Wednesday, January 28, 2009
Room 020B, 9200 Corporate Blvd.


Kate Cook, CDRH.

FDA MDUFMA / MDUFA Performance — Actions through Dec. 31, 2008

  • Reports on all decision goals for the FY 2003 – FY 2008 cohorts.
  • Data on total review times (time with FDA plus time with the company) from receipt / filing to final decision for 510(k)s, PMAs and panel-track supplements, expedited PMAs and expedited panel-track supplements, and 180-day PMA supplements. Combined CBER and CDRH data. Barbara Zimmerman, CDRH-ODE.

Qualitative Update on Finances

  • First quarter FY 2009 user fee receipts, compared with expectations, and an update on reconciliation of FY 2008 user fee receipts Helio Chaves, FDA-OFM.

  • Update on FY 2008 user fee receipts. Helio Chaves, FDA-OFM.

  • Qualitative Update on Finances. Maria Boyreau, CDRH-OMO.

Overview of FDA Medical Device Guidance Issued During the First Quarter

  • Overview. FDA issued four guidance documents during the first quarter of FY 2009. Cathy Norcio, CDRH-OCD.

  • Brief summary of each guidance. Barbara Zimmerman, CDRH-ODE; Bob Yetter, CBER.

Status of FY 2009 Establishment Registration Process

Terry McDonald, CDRH-OC

  • As of January 1, all existing establishments should have registered, listed, and paid the FY 2009 registration fee.

  • As of January 1, 2009, approximately 12,442 establishments had paid the FY 2009 fee (97% of the baseline target of 12,750 establishments), but only 10,848 establishments had actually registered / listed.

  • For comparison, as of January 1, 2008, only about 6,560 establishments had paid the registration fee for FY 2008 (51.5% of the baseline target), but FY 2008 still ended “in the black,” with more than 13,800 establishments paying.

  • FDA’s plans to contact establishments to ensure compliance with the requirement to register / list, and the requirement to pay a registration fee when required.

  • If fewer than 12,250 establishments register, section 738(c)(2) requires FDA to adjust the registration fee for FY 2010 by adding up to an additional 8.5% to the base fee for FY 2010 (the base fee is $2,008, so the maximum adjustment would add $171 to the FY 2010 fee). Registration fees for FY 2011 and FY 2012 would increase 8.5% each year over the adjusted FY 2010 fee.

GAO and Congressional Oversight Relating to FDAAA

Kate Cook, CDRH-OCD.

  • GAO has completed their study of the 510(k) process.

  • Report to Congress — Under section 515A(a)(3), FDA must report to Congress annually concerning certain device approvals:

    • devices for which there is a pediatric subpopulation that suffers from the disease or condition that the device is intended to treat, diagnose, or cure;

    • devices labeled for use in pediatric patients; and

    • devices for which the review fee was waived because the device is intended solely for use in a pediatric population.

The first report to Congress is due March 2009.

Update on Unique Device Identification

Kate Cook, CDRH

Public Workshop scheduled, February 12, 2009, 9:00 a.m. – 5:00 p.m., at the Marriott Gaithersburg Washingtonian Center.


  • General discussion, questions.

  • Set date for next meeting. FDA must extend the time to prepare for future meetings, due to the need to convert all Internet document to comply with the accessibility requirements of section 508 of the Disabilities Act (29 U.S.C. § 794d). Target: May 4-8, 2009 (five weeks following close of FY 2009 Q1)

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