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Agenda and Materials From January 28, 2009 FDA Performance Report

• Agenda
• Medical Device Guidance Documents Issued During FY 2009
• Quarterly Update on Medical Device Performance Goals - CDRH Performance Data (Printer Version)
• Quarterly Update on Medical Device Performance Goals - CBER Performance Data (Printer Version)
• FY 2009 and FY 2008 Medical Device User Fee Collections

Agenda

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

Welcome

   Kate Cook, CDRH.

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

• Reports on all decision goals for the FY 2003 – FY 2008 cohorts.
  • CBER report: Bob Yetter, CBER.
  • CDRH report: Barbara Zimmerman, CDRH-ODE.
• 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.

Discussion

• 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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Medical Device Guidance Documents
Issued During FY 2009

Through December 31, 2008

First Quarter (October 2008 – December 2008) — 4 Publications

Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300 — 12/23/2008

Draft Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Expander – 12/22/2008

Draft Guidance for Industry and FDA Staff: Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile — 12/12/2008

Guidance for Industry and FDA Staff – Modifications to Devices Subject to Premarket Approval (PMA) – The PMA Supplement Decision–Making Process – 12/11/2008

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Quarterly Update on Medical Device Performance Goals - CDRH Performance Data

Actions through December 31, 2008

Data on FY 2003 – FY 2007 Cohorts

PMAs and Panel-Track Supplements
CDRH Actions through December 31, 2008

PMA and Panel Track PMA Supplements
Percent of CDRH Decisions Meeting 320-day MDUFMA Goal

• Progress to date indicates CDRH will likely meet the goals for FY 2006 and FY 2007.
• The FY 2003 and FY 2004 cohorts are complete. All other cohorts remain open.

Expedited PMAs
CDRH Actions through December 31, 2008

Expedited PMAs
Percent of CDRH Decisions meeting MDUFMA Goal

• FY 2003 and FY 2005 cohorts are complete; all other cohorts remain open.
• Because of the small number of Expedited PMAs, a single action may signficantly affect performance measures.

180-day PMA Supplements
CDRH Actions through December 31, 2008

180-day PMA Supplements
Percent of CDRH Decisions Meeting MDUFMA Goal

• FY 2003, FY 2004, and FY 2005 cohorts are complete.

510(k) Premarket Notifications
CDRH Actions through December 31, 2008

¹ The MDUFMA Cohort excludes 510(k)s that were closed for any reason other than an SE or NSE decision (e.g., when FDA finds that a 510(k) was not required). The number of 510(k)s in the MDUMFA Cohort is subject to change until the cohort is complete.

510(k) Premarket Notifications
Percent of CDRH Decisions Meeting MDFUMA Goal

• FY 2003 and FY 2004 cohorts are closed; only one 510(k) remains open in the FY 2005 cohort, six in the FY 2006 cohort, and 68 in the FY 2007 cohort.

Data on FY 2008 – FY 2012 Cohorts

PMAs and Panel-track PMA Supplements
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Expedited PMAs and Expedited Panel-track Supps
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

PMA Modules
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

180-Day PMA Supplements
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

Real-time PMA Supplements
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

510(k) Premarket Notification
Percent of CDRH Decisions Meeting FY 2008 - FY 2012 Goals

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Quarterly Update on Medical Device Performance Goals - CBER Performance Data

Document currently only available in PDF format.

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FY 2009 and FY 2008 Medical Device User Fee Collections

Notes:

1. The Authorized revenues shown for Establishment Registration fees assume 12,750 establishments will register and pay the fee of $1,851.
2. The Authorized revenues shown for Application / Reporting Fees represents the difference between total authorized fee revenues and the
   amount shown for authorized Establishment Registration revenues.
3. Nearly all of these amounts are believed to be attributable to establishment registration fees.
4. Total FY 2008 authorized fee revenues are specified in section 738(h)(3) of the FD&C Act.

Notes:

1. The Authorized revenues shown for Establishment Registration fees assume 12,750 establishments will register and pay the fee of $1,706.
   During FY 2008, 13,869 establishments registered and paid the fee.
2. The Authorized revenues shown for Application / Reporting Fees represents the difference between total authorized fee revenues and the
   amount shown for authorized Establishment Registration revenues.
3. Nearly all of these amounts are believed to be attributable to establishment registration fees.
4. Total FY 2008 authorized fee revenues are specified in section 738(h)(3) of the FD&C Act.

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Updated March 2, 2009

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