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Agenda and Materials From May 4, 2009 FDA Performance Report

• Agenda
• Quarterly Update on Medical Device Performance Goals -- CBER Performance Data
• Quarterly Update on Medical Device Performance Goals -- CDRH Performance Data
• CDRH 510(k) Premarket Notifications, FY 2003 - FY 2008
• CDRH Real-Time PMA Supplements, FY 2003 - FY 2008
• Comparison of Review Time Performance of CDRH 180-day PMA Supplements
• CLIA Waiver Decisions Made During FY 2008
• FY 2009 Establishment Registration ­-- Fee Payments and Completed Registrations
• Medical Device Registration and Listing Data for FY 2009
• CDRH Relocation to White Oak
• Medical Device Guidance Documents Issued During FY 2009
• FY 2009 Medical Device User Fee Collections
• FY 2009 Medical Devices Appropriation
• Information Management Initiatives, 2009
• FY 2009 Staff College Internal Training Report

Agenda for Quarterly Meeting on MDUFMA / MDUFA Performance

1:00 – 3:00, Monday, May 4, 2009
Room 020B, 9200 Corporate Blvd

Welcome. Kate Cook, CDRH-OCD.

FDA MDUFMA / MDUFA Performance — Actions through March 31, 2009

• Reports on all decision goals for the FY 2003 - FY 2009 cohorts.
• CBER: Leonard Wilson.
• CDRH: Barbara Zimmerman, ODE.
• Comparative data from CDRH — Donna-Bea Tillman, ODE.
• 510(k) premarket notifications: NSE decisions. FY 2003 – FY 2008
• Real-time PMA supplements: “not approvable” decisions, FY 2003 – FY 2008
• 180-day PMA supplements: cumulative data for FY 2003 – FY 2007, compared with FY 2008

First Annual Report on Review Times of CLIA Waiver Applications

• Paragraph I.N.4. of the October 27, 2007 commitment letter calls for FDA to track review times for CLIA waiver applications, and to share this information with industry annually. This first report covers FY 2008. Don St. Pierre, CDRH-OIVD.

Update on Electronic Registration and Listing — Terry McDonald, CDRH-OC.

• Latest counts of establishments registered for FY 2009, and latest information on payment of registration fees for FY 2009 (we’re received more payments than registrations).
• Preliminary finding that FY 2008 and FY 2009 registrations appear to have met the statutory threshold, so no special adjustment of FY 2010 – FY 2012 registration fees will be required (fees will continue to increase at the standard 8.5% annual rate specified by law).
• Data on establishments registered for FY 2009 and their device listings.
• Follow-up on outstanding registration questions.

CDRH’s Move to White Oak

•  CDRH’s plans for its upcoming move to FDA’s White Oak campus.
  Frank Benedetti, CDRH-OFM.

Overview of FDA Medical Device Guidance Issued During FY 2009 Q1 and Q2 —
Donna-Bea Tillman, CDRH-ODE; Leonard Wilson, CBER; Don St. Pierre, CDRH-OIVD.

• FDA issued five medical device guidance documents during the second quarter.

Qualitative Update on Finances and Use of Resources — Q1 and Q2, FY 2009

• User fee receipts for the first six months of FY 2009, compared with expectations — David Caines, FDA-OFM.
• FY 2009 medical device program appropriations — Maria Boyreau, CDRH-OMO-DPAF.
• FY 2009 IT initiatives and progress — Phil Bennett, CDRH-OCD.
• FY 2009 MDUFMA-related training — Jacqueline Woodard, CDRH-OCER.

Discussion

• Questions from industry.
• Set date for next meeting, following close of Q3. Target: Week of August 4-7.

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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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Quarterly Update on Medical Device Performance Goals - CDRH Performance Data

Actions through 31 March 2009
Data on FY 2003 – FY 2007 Cohorts

PMAs and Panel-Track Supplements
CDRH Actions through 31 March 2009

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 31 March 2009

Expedited PMAs
Percent of CDRH Decisions Meeting MDUFMA Goal

• The FY 2004 cohort remains open (a single application); all other cohorts are closed.
• Because of the small number of Expedited PMAs, a single action may signficantly affect performance measures.

180-day PMA Supplements
CDRH Actions through 31 March 2009

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 31 March 2009

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 MDUFMA Goal

• FY 2003 and FY 2004 cohorts are closed; only one 510(k) remains open in the FY 2005 cohort, two in the FY 2006 cohort, and 17 in the FY 2007 cohort.

Data on FY 2008 – FY 2012 Cohorts

PMAs and Panel-track PMA Supplements
Percent of CDRH Decisions Meeting FY2008-FY2012 Goals

PMA Modules
Percent of CDRH Decisions Meeting FY2008-FY2012

180-day PMA Supplements
Percent of CDRH Decisions Meeting FY2008-FY2012 Goals

Real-time PMA Supplements
Percent of CDRH Decisions Meeting FY2008-FY2012 Goals

510(k) Premarket Notifications
Percent of CDRH Decisions Meeting FY2008-FY2012 Goals

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CDRH 510(k) Premarket Notifications, FY 2003 - FY 2008

Data as of 15-April-2009
All decisions = SE decisions + NSE decisions
Other outcomes = Final actions other than SE and NSE, e.g., withdrawal, deletion, not a device.
All outcomes = SE decisions + NSE decisions + Other outcomes
510(k)s with AN ("approved de novo") decision code are included in NSE counts.
510(k)s with CP ("called for PMA") decision code are included in SE counts.

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CDRH Real-Time PMA Supplements, FY 2003 - FY 2008

Data as of 21-April-2009
"Not Approvable"
Other Outcomes = Final actions other than FDA Decisions, e.g., Withdrawal, Other.
All Outcomes = FDA Decisions + Other Outcomes.

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Comparison of Review Time Performance of CDRH 180-day PMA Supplements

Using MDUFA Two-Tier Performance Measuers

Caveat: Data for FY 2003 - FY 2007 is not strictly comparable to data for FY 2008 and later years. Beginning with FY 2008, the process for review of 180-day PMA supplements allows FDA to issue "major deficiency" letters, allowing the applicant an opportunity to correct deficiencies without terminating FDA's review. Prior to FY 2008, FDA issued a "not approvable" letter in similar situations. A "not approvable" decision counts as an "FDA decision", while a "major deficiency" letter does not.

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CLIA Waiver Decisions Made During FY 2008

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FY 2009 Establishment Registration ­ Fee Payments and Completed Registrations

Fee Payments and Completed Registrations as of March 31, 2009

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Medical Device Registration and Listing Data for FY 2009

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CDRH Relocation to White Oak

CDRH Components Relocating

• Moves begin mid-May and should be completed by the end of July.
• OIVD and ODE moves are scheduled in late June and July.
• Once completed, it will be the first time that all CDRH components are in one location.

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Medical Device Guidance Documents Issued During FY 2009

Through March 31, 2009

* indicates a guidance required by FDAAA or the FDA commitment letter, or issued to implement a FDAAA provision.

Second Quarter (January 2009 – March 2009) — Five publications

• * Draft Guidance for Industry and FDA Staff: User Fees and Refunds for Premarket Approval Applications — 3/13/2009
• Guidance for Industry and FDA Staff: Recommendations for Anti-Nuclear Antibody (ANA) Test System Premarket (510(k)) Submissions — 1/22/2009
• Guidance for Industry: Designation of Special Controls for Male Condoms Made of Natural Rubber Latex — 1/5/2009
• * Draft Guidance for Industry and FDA Staff: Assay Migration Studies for In Vitro Diagnostic Devices — 1/5/2009 — Required by paragraph I.O.1.(c) of the FDA commitment letter.
• * Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Nucleic Acid Amplification Assay for the Detection of Enterovirus RNA — 1/2/2009 — Required by paragraph I.O.1.(e) of the FDA commitment letter.

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

• Guidance for Industry and FDA Staff: Radiation Safety Considerations for X-Ray Equipment Designed for Hand-Held Use — 12/24/2008
• 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 — 12/22/2009
• 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 — 12/11/2009

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FY 2009 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. The Authorized revenues shown for Application / Reporting Fees represents the difference between the Total authorized fee revenues and the amount shown for authorized Establishment Registration revenues. Total FY 2009 authorized fee revenues are specified in section 738(h)(3) of the FD&C Act.

2. Expected to date reflects the percentage of revenue we should have collected to the date of this report. Because all establishment registrations should be completed in the first quarter of each year, see sections 510(b)(2) and 510(i)(1)(B)(ii) of the FD&C Act, we expect 100% of establishment registration fees to be paid in the first quarter. We expect application / reporting fees to be paid in a steady stream, with 25% of expected revenue being paid each quarter. The following table illustrates these expectations.

3. Nearly all of these amounts are believed to be attributed to establishment registration fees.

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FY 2009 Medical Devices Appropriation

The Omnibus Appropriations Act, 2009 (H.R. 1105) was signed on March 11, 2009, providing FDA its annual appropriation for FY 2009. FDA received an appropriation of $280,587,000 for the medical device program, an increase of 8.7% over last year’s appropriation. Medical device user fee revenues are increased 8.5%; see section 738(h)(3).

During FY 2009, FDA is focusing on initiatives that include:

1. UDI system development
2. Import Safety: including capacity building, with education of foreign countries and support of FDA foreign offices
3. Pediatric Device Development (pediatric projects, including BPA research; guidance and standards; etc.)
4. IT system enhancements
5. Critical Path activities
6. Basic Science to improve product development and postmarket safety. The areas include:
   1. Biomarker modeling;
   2. High throughput methods for detection and identification of contaminants and emerging diseases, and;
   3. Clinical trial design and analysis methods
7. CBER and CDRH will maintain the high quality and timely review of premarket submissions.

During FY 2009, our recruitment efforts are targeting the following types of expertise:

• medical officers,
• statisticians,
• engineers,
• interdisciplinary scientists (chemists, microbiologists, medical technologists),
• consumer safety officers,
• public health officers, and
• support staff for advisory panel activities.

These recruitments will allow FDA to:

• Enhance clinical infrastructure to meet expanding FDA priorities.
• Expand the in vitro diagnostics patient safety initiative.
• Enhance our statistical infrastructure to meet expanding FDA priorities.
• Hire additional clinicians and engineers to support medical device reviews.
• Establish a personalized medicine staff within CDRH-OIVD.
• Increase the development of additional guidance, support of standards, and reclassification of devices.
• Increase our support of Advisory Panel activities.

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Information Management Initiatives, 2009

May 2009 Update

• Over the last year, considerable resources have been expended to convert CDRH legacy systems in preparation for migration to the new data centers at White Oak and Ashburn, Virginia.
• MDUFMA funds directly support the management of Center Electronic Submissions (CeSub) development and enhancements and provide direct user support to industry. In the last month, a new change control board has been chartered, chaired by Barbara Zimmerman, to guide the management of improvements to the CeSub system. Over the last six months many enhancements have been made to the eSubmitter portion of CeSub including updates to many templates and modification of the software to receive CVM and CBER submissions as well as CDRH, the latter not MDUFMA funded. Planning is underway to develop an interactive review application to enhance the quality and consistency of both the review and documentation for 510K submissions—this will be developed under ODE management with other offices participating,
• Under the umbrella of postmarket transformation and as part of the implementation of the Matrix at CDRH, social networking software has been piloted at the Center to improve the sharing of information and to facilitate collaboration and communication. The Center is planning the phased implementation of these capabilities in support of various business processes and the total product life cycle (TPLC). Other Centers and FDA management have also expressed interest in CDRH’s progress in this area for wider application.
• The FURLS registration and listing software, although not funded by MDUFMA, continues to be updated and enhanced on a regular basis with current contract support extended to December 2010. Planning for FURLS is coordinated with HI planning.
• Although not supported by MDUFMA, major improvements are underway to bolster the capability and reliability of the electronic gateway to receive increased electronic submission across the agency.
• Two of our major management and data management tools, Center Tracking System (CTS) and the CARS data warehouse have had a number of releases over the last six months. CTS has had two major releases including additional tracking for Good Manufacturing Processes and Bioresearch monitoring reviews of PMA, Modular PMA and HDE submissions.
• The CARS data warehouse has had 3 releases since November, targeted at improving access to and management of data for reviewers. A major release of CARS is planned for later in 2009, which will add additional data from CDRH applications toward the goal of providing a TPLC view of the data.

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FY 2009 Staff College Internal Training Report

From 10/01/2008 to 03/31/2009

As of: 04/09/2009

*Course Completions = Successful attendance in a Learning Event

Key: LAW = Law & Policy, LED = Leadership,
PRO = Professional Development, SCI = Science

* Unique Students = Number of distinct students

Updated May 4, 2009

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