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Medical Devices

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Agenda and Materials From May 4, 2009 FDA Performance 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 ListingTerry 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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 PDF Printer VersionQuarterly 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

Workload (Applications Filed to Date)
 FY 2003FY 2004FY 2005FY 2006FY 2007
PMAs4039413733
Panel-Track Supplements7811164
Total Workload4747525337
FDA Decisions
 FY 2003FY 2004FY 2005FY 2006FY 2007
FDA Decisions4747515035
Goal – Percent within 320 days80%90%
Percent of decisions within 320 days91.5%91.5%86.3%80.0%91.4%
Applications without a decision00132
Cohort statusCompleteCompleteOpenOpenOpen
Goal – Percent within 180 days50%
Percent of decisions within 180 days44.7%36.2%33.3%36.0%57.1%

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

Graph, percentage versus fiscal year. For FY2003, 91.5%. For FY2004, 91.5%. For FY2005, 86.3%. For FY2006, 80.0%. For FY2007, 91.4%.

  • 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

Workload (Applications Filed to Date)
 FY 2003FY 2004FY 2005FY 2006FY 2007
Expedited PMAs314622
FDA Decisions
 FY 2003FY 2004FY 2005FY 2006FY 2007
FDA Decisions313622
Goal – Percent within 300 days70%80%90%
Percent of decisions within 300 days100.0%92.3%83.3%50.0%0
Applications without a decision01000
Cohort statusCompleteOpenCompleteClosedClosed

Expedited PMAs
Percent of CDRH Decisions Meeting MDUFMA Goal

Graph, percentage versus fiscal year. For FY2003, 100%. For FY2004, 92.3%. For FY2005, 83.3%. For FY2006, 50%. For FY2007, 0%.

  • 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

 Workload
 FY 2003FY 2004FY 2005FY 2006FY 2007
180-day PMA Supplements20110399134140
 FDA Decisions
 FY 2003FY 2004FY 2005FY 2006FY 2007
FDA Decisions20110399133139
Goal – Percent within 180 days80%80%90%
Percent of decisions within 180 days94.0%95.1%94.9%96.2%92.1%
Applications without a decision00011
Cohort statusCompleteCompleteCompleteOpenOpen

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

Graph, percentage versus fiscal year. For FY2003, 94%. For FY2004, 95.1%. For FY2005, 94.9%. For FY2006, 96.2%. For FY2007, 92.1%.

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

510(k) Premarket Notifications
CDRH Actions through 31 March 2009

 Workload
 FY 2003FY 2004FY 2005FY 2006FY 2007
Received4,2253,6323,6503,8533,656
MDUFMA Cohort¹3,7413,3093,3453,4493,185

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.

 FDA Decisions (SE and NSE Determinations)
 FY 2003FY 2004FY 2005FY 2006FY 2007
FDA Decisions (SE and NSE)3,7413,3093,3443,4473,168
Goal – Percent within 90 days75%75%80%
Percent of decisions within 90 days75.7%83.6%91.0%91.2%91.2%
Remaining Applications001217
Cohort statusCompleteCompleteOpenOpenOpen

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

Graph, percentage versus fiscal year. For Fy2003, 75.7%. For FY2004, 83.6%. For FY2005, 91%. For FY2006, 91.2%. For FY2007, 91.2%.

  • 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 Supplements
 FY 2008FY 2009FY 2010FY 2011FY 2012
Workload (Filed to Date)3313---
Total FDA Decisions160---
Percent within Tier 1 goal (180 days)100%----
Tier 1 goal - Percent within 180 days60%60%60%60%60%
Percent within Tier 2 goal (295 days)100.0%0.0%---
Tier 2 goal - Percent within 295 days90%90%90%90%90%
Cohort statusOpenOpen---

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

Graph, percentage versus fiscal year. For FY2008, decisions within Tier 1 were 100%, and decisions within Tier 2 were 100%. For all future years, zero percent.

 PMA Modules
 FY 2008FY 2009FY 2010FY 2011FY 2012
Workload (Filed to Date)4331---
Total FDA Decisions4516---
Percent within Tier 1 goal (90 days)51.1%75.0%---
Tier 1 goal - Percent within 90 days75%75%75%75%75%
Percent within Tier 2 goal (120 days)91.1%100.0%---
Tier 2 goal - Percent within 120 days90%90%90%90%90%
Cohort statusOpenOpen---

PMA Modules
Percent of CDRH Decisions Meeting FY2008-FY2012

Graph, percentage versus fiscal year. For FY2008, decisions within tier 1, 51.1%, within tier 2, 91.1%. For FY2009, decisions within tier 1, 75%, within tier 2, 100%. All future years, zero percent.

 180-day PMA Supplements
 FY 2008FY 2009FY 2010FY 2011FY 2012
Workload (Filed to Date)17090---
Total FDA Decisions14214---
Percent within Tier 1 goal (180 days)96.5%100.0%---
Tier 1 goal - Percent within 180 days85%85%85%85%85%
Percent within Tier 2 goal (210 days)98.6%100.0%---
Tier 2 goal - Percent within 210 days95%95%95%95%95%
Cohort statusOpenOpen---

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

Graph. Percentage versus fiscal year. For FY2008, decisions within tier 1, 96.5%. Decisions within tier 2, 98.6%. For FY2009, decisions within tier 1 and 2 both 100%. All future years, zero percent.

 Real-time PMA Supplements
 FY 2008FY 2009FY 2010FY 2011FY 2012
Workload (Filed to Date)248167---
Total FDA Decisions238108---
Percent within Tier 1 goal (60 days)96.6%100.0%---
Tier 1 goal - Percent within 60 days80%80%80%80%80%
Percent within Tier 2 goal (90 days)98.3%100.0%---
Tier 2 goal - Percent within 90 days90%90%90%90%90%
Cohort statusOpenOpen---

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

Graph, percentage versus fiscal year. For FY2008, decisions within tier 1, 96.6%. Decisions within tier 2, 98.3%. For FY2009, decisions within tier 1 and 2 both 100%. For future years, zero percent.

 510(k)s
 FY 2008FY 2009FY 2010FY 2011FY 2012
Workload (Filed to Date)3,8481,925---
MDUFMA Cohort3,3951,873---
Total FDA Decisions3,082690   
Percent within Tier 1 goal (90 days)95.5%98.3%---
Tier 1 goal - Percent within 90 days90%90%90%90%90%
Percent within Tier 2 goal (150 days)99.4%100.0%---
Tier 2 goal - Percent within 150 days98%98%98%98%98%
Cohort statusOpenOpen---

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

Graph, percentage versus fiscal year. For FY2008, decisions within tier 1, 95.5%. Decisions within tier 2, 99.4%. For FY2009, decisions within tier 1, 98.3%, within tier 2, 100%. For future years, 0%.

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

CDRH 510(k) Premarket Notifications, FY 2003- FY 2008 (Receipt Cohorts)
 FY 2003FY 2004FY 2005FY 2006FY 2007FY 2008
Receipts4,2253,6323,6503,8533,6563,848
SE and NSE Decisions3,7413,3103,3443,4473,1473,106
NSE122121133144129117
% of all decisions3.3%3.7%4.0%4.2%4.1%3.8%
% of all outcomes2.9%3.3%3.6%3.7%3.5%3.3%
SE3,6193,1893,2113,3033,0452,989
% of all decisions96.7%96.3%96.0%95.8%95.9%96.2%
% of all outcomes85.7%87.8%88.0%85.8%83.7%83.7%
Other Outcomes484322305404466463
% of all outcomes11.5%8.9%8.4%10.5%12.8%13.0%
All Outcomes4,2253,6323,6493,8513,6403,569
Still pending001216279
% of receipts0.0%0.0%0.0%0.1%0.4%7.3%

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

CDRH Real Time PMA Supplements, FY 2003 - 2008 (Receipt Cohorts)
 FY 2003FY 2004FY 2005FY 2006FY 2007FY 2008
Receipts193195196291265249
FDA Decisions190183190274259240
"Not Approvalable"699151223
% of all decisions3.2%4.9%4.7%5.5%4.6%9.6%
% of all outcomes3.1%4.6%4.6%5.2%4.5%9.3%
Other Outcomes31261658
% of all outcomes1.6%6.2%3.1%5.5%1.9%3.2%
All Outcomes193195196290264248
Still Pending000111
% of all outcomes0.0%0.0%0.0%0.3%0.4%13.0%

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.

 
FY 2003 -
FY 2007
FY 2008
Number of Submissions Received673170
Decisions Made through March 31, 2009:  
Percent of Decisions within Tier 1 (180 days)97.5%96.4%
Percent of Decisions within Tier 2 (210 days)98.6%98.6%
Best-case Projection (to completion of cohort):  
Percent of Decisions within Tier 1 (180 days)97.2%95.7%
Percent of Decisions within Tier 2 (210 days)98.3%98.8%
Worst-case Projection (to completion of cohort):  
Percent of Decisions within Tier 1 (180 days)97.2%82.3%
Percent of Decisions within Tier 2 (210 days)98.3%84.1%

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CLIA Waiver Decisions Made During FY 2008

 CLIA Waiver Decisions Made During FY 2008
FDA Decisions Review Times
FDA DaysMFG DaysTotal
APPR - Approved61061
APPR - Approved24838286
APPR - Approved24838286
APPR - Approved3980398
APPR - Approved3980398
 Average Time for Approvals27115286
DENY - Denied56056
DENY - Denied1020102
DENY - Denied1290129
DENY - Denied1890189
DENY - Denied1990199
DENY - Denied2870287
 Average Time for Denials1600160
 Average Time for All Decisions2107217

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FY 2009 Establishment Registration ­ Fee Payments and Completed Registrations

Fee Payments and Completed Registrations as of March 31, 2009

Approximate number of establishments that have paid the registration fee for FY 2009; some of these have not yet registered.13,915 
Registrations completed as of March 31, 2009; all of these establishments are subject to, and have paid, the establishment registration fee.13,035 
Section 738(c)(2) fee-adjustment trigger.<12,250 

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Medical Device Registration and Listing Data for FY 2009

Medical Device Registration and Listing Data for FY 2009
Status as of April 3, 2009
An establishment that could be included in more than one Establishment Type category is assigned to a single category according the to ranking shown in the left-most column. For example, if an establishment is both a manufacturer and a contract manufacturer, it is counted only as a manufacturer. Similarly, if an establishment has listed devices in more than one class, it is counted only in the highest class. For example, if an establishment has listed both a class I device and a class II device, it is counted only under class II.
  Number of Establishments Registered, by Highest Class of Device Listed 
  Domestic EstablishmentsForeign Establishments 
RankEstablishment TypeClass IClass IIClass IIITotalClass IClass IIClass IIITotalTotal
Registered
Establishments
Establishments Subject to MDUFA Registration Fee
1Manufacturer1,5882,6903804,6583,0682,6262105,90410,562
2Contract Manufacturer1181552429727127525571868
3Contract Sterilizer9601514702136
4Specification Developer519665621,24610113962461,492
5Reprocessor of Single-Use Devices212014100115
6U.S. Manufacturer of Export-Only Devices7253062000062
Total, Subject to MDUFMA Fee2,2433,5534966,2923,4553,0472416,74313,035
Establishments Not Subject to MDUFA Registration Fee
7Repackager / Relabeler560377279641686232331,197
8Remanufacturer172604324803275
9Foreign Exporter   050315611670670
10Initial Distributor / Importer   3,622   03,622
11Unknown   86   62148
Total, Not Subject to MDUFMA Fee577403274,715695226149975,712
All Registered Establishments
Total, All Registered Establishments2,8203,95652311,0074,1503,2732557,74018,747

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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

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

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FY 2009 Medical Device User Fee Collections

 FY 2009 Medical Device User Fee Collections
As of March 31, 2009
SourceFY 2009
Authorized 1
Expected
to Date 2
FY 2009 Fee RevenuesFY 2009 Surplus (Deficit)
ReceiptsRefundsNet% of Authorized% of Expectedcf. Authorizedcf. Expected
Establishment Registration Fees$23,600,250$23,600,250$26,009,389$251,157$25,758,232109.1%109.1%$2,157,982$2,157,982
Application / Reporting Fees$28,946,750$14,473,375$17,186,073$92,123$17,092,95059.0%118.1%$11,853,800 (Deficit)$2,619,575
Uncategorized3  $314,786$-$314,786  $314,786$314,786
Total$52,547,000$38,073,625$43,510,248$344,280$43,165,96882.1%113.4%$9,381,032 (Deficit)$5,092,343

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.

 Cumulative Percent of Authorized Amounts Expected During the Fiscal Year
Source of Revenue Close of Quarter Ending
December 31March 31June 30September 30
Establishment Registration Fees100%100%100%100%
APPR - Approved25%50%75%100%

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

Comparison:
Medical Device User Fee Collection in Prior Years
Excludes Unearned Fees, Includes Refunds
Fy 2003FY 2004FY 2005FY 2006 30FY 2007FY 2008
$21,620,549$25,309,853$31,801,091$34,567,188$26,893,394$48,731,246

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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

Table X: MDUFMA Related Internal Training
Topical Area# of CoursesTotal# of ParticipantsExamples of Training Conducted/Attended Between October 1, 2008- March 31, 2009
Regulatory and Law (LAW)11427
  • Reviewer Training: 510(k) Essentials
  • Product Codes: Make the Connection
  • Medical Device Law
  • Basic Food and Drug Law
  • Guidance Prioritization and Development
  • Interactive Review of PMAs and 510(k)s
  • Advanced Topics in Regulatory Issues: STED
Science (SCI)81825
  • The New Practice of Public Health
  • Hierarchical Bayesian Methods & Software for
  • Data Analysis
  • EMC Requirements for Medical Products
  • Introduction to Medical Device Software Risk
  • Management
  • Pesticides and Nanotechnology
  • Epidemiology Grand Rounds
  • Network Presentations – Huber Needles
  • CDRH Science Grand Rounds: Adhesion Barriers
  • Neurology Meet the Experts (2 sessions)
  • High Performance Computing Technologies & Applications in Medicine
Leadership Education & Development (LED)8178
  • Situational Leadership
  • FDA Human Resources Management for  Supervisors
  • Team of Rivals
  • Effective Presentation Skills
Professional Development37674
  • Building a Winning Scientific & Technical Team
  • Speaking Under Fire
  • Change Management
  • Executive Grammar
  • Decision Analysis for Decision Makers
  • Basics of Good Report Writing
  • Handling People with Diplomacy and Tact
TOTAL872104 

FY09 completion summary data for CDRH staff college internal learning events, october 1 2008 through march 31 2009. Unique students (number of distinct students), 766. Course completions (successful attendance in a learning event), 2113. Courses, 89. SCOL contact hours, 10846. Data date april 9, 2009.

CDRH FY09 internal training summary october 1 2008 through march 31 2009, science and law learning events. For law, 434 student completions, 294 unique students, 12 learning events, and 2399 contact hours. For sci, 825 student completions, 450 unique students, 31 learning events, 1998.5 contact hours.

CDRH FY09 internal training summary october 1 2008 through march 31 2009, leadership and professional development learning events. For leadership, 178 student competions, 117 unique students, 8 learning events, 1149 contact hours. For professional development, 676 student completions, 409 unique students, 38 learning events, 5299 contact hours.

CDRH total distribution FY09, october 1 2008 through march 31 2009. Student course completion by category (successful attendance in a learning event). Law, 434, 20.5%. Leadership, 178, 8.4%. Professional development, 676, 32%. Science, 825, 39%. Total, 2113, 100%.

*Course Completions = Successful attendance in a Learning Event

CDRH total distribution FY09 October 1 2008 through march 31 2009. Contact hours by category. Law, 2399 hours, 22.1%. Leadership, 1149 hours, 10.6%. Professional development, 5299 hours, 48.9%. Science, 1999 hours, 18.4%. Total hours 10846.

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

CDRH total distribution FY09 October 1, 2008 through March 31, 2009. Staff College learning events by category. Law, 12, 13.5%. Leadership, 8, 9%. Professional development, 38, 42.7%. Science, 31, 34.8%. Total, 89, 100%.

CDRH total distribution FY09 October 1 2008 through March 31 2009. Unique student count by category (number of distinct students). Law, 294 students. Leadership, 117 students. professional development, 409 students. Science, 450 students.

* Unique Students = Number of distinct students