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

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 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

Workload (Applications Filed to Date)

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007
PMAs	40	39	41	37	33
Panel-Track Supplements	7	8	11	16	4
Total Workload	47	47	52	53	37

FDA Decisions

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007
FDA Decisions	47	47	51	50	35
Goal – Percent within 320 days	—	—	—	80%	90%
Percent of decisions within 320 days	91.5%	91.5%	86.3%	80.0%	91.4%
Applications without a decision	0	0	1	3	2
Cohort status	Complete	Complete	Open	Open	Open
Goal – Percent within 180 days	—	—	—	—	50%
Percent of decisions within 180 days	44.7%	36.2%	33.3%	36.0%	57.1%

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

Workload (Applications Filed to Date)

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007
Expedited PMAs	3	14	6	2	2

FDA Decisions

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007
FDA Decisions	3	13	6	2	2
Goal – Percent within 300 days	—	—	70%	80%	90%
Percent of decisions within 300 days	100.0%	92.3%	83.3%	50.0%	0
Applications without a decision	0	1	0	0	0
Cohort status	Complete	Open	Complete	Closed	Closed

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

 Workload

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007
180-day PMA Supplements	201	103	99	134	140

 FDA Decisions

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007
FDA Decisions	201	103	99	133	139
Goal – Percent within 180 days	—	—	80%	80%	90%
Percent of decisions within 180 days	94.0%	95.1%	94.9%	96.2%	92.1%
Applications without a decision	0	0	0	1	1
Cohort status	Complete	Complete	Complete	Open	Open

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

 Workload

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007
Received	4,225	3,632	3,650	3,853	3,656
MDUFMA Cohort¹	3,741	3,309	3,345	3,449	3,185

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 2003	FY 2004	FY 2005	FY 2006	FY 2007
FDA Decisions (SE and NSE)	3,741	3,309	3,344	3,447	3,168
Goal – Percent within 90 days	—	—	75%	75%	80%
Percent of decisions within 90 days	75.7%	83.6%	91.0%	91.2%	91.2%
Remaining Applications	0	0	1	2	17
Cohort status	Complete	Complete	Open	Open	Open

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 Supplements

	FY 2008	FY 2009	FY 2010	FY 2011	FY 2012
Workload (Filed to Date)	33	13	-	-	-
Total FDA Decisions	16	0	-	-	-
Percent within Tier 1 goal (180 days)	100%	-	-	-	-
Tier 1 goal - Percent within 180 days	60%	60%	60%	60%	60%
Percent within Tier 2 goal (295 days)	100.0%	0.0%	-	-	-
Tier 2 goal - Percent within 295 days	90%	90%	90%	90%	90%
Cohort status	Open	Open	-	-	-

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

 PMA Modules

	FY 2008	FY 2009	FY 2010	FY 2011	FY 2012
Workload (Filed to Date)	43	31	-	-	-
Total FDA Decisions	45	16	-	-	-
Percent within Tier 1 goal (90 days)	51.1%	75.0%	-	-	-
Tier 1 goal - Percent within 90 days	75%	75%	75%	75%	75%
Percent within Tier 2 goal (120 days)	91.1%	100.0%	-	-	-
Tier 2 goal - Percent within 120 days	90%	90%	90%	90%	90%
Cohort status	Open	Open	-	-	-

PMA Modules
Percent of CDRH Decisions Meeting FY2008-FY2012

 180-day PMA Supplements

	FY 2008	FY 2009	FY 2010	FY 2011	FY 2012
Workload (Filed to Date)	170	90	-	-	-
Total FDA Decisions	142	14	-	-	-
Percent within Tier 1 goal (180 days)	96.5%	100.0%	-	-	-
Tier 1 goal - Percent within 180 days	85%	85%	85%	85%	85%
Percent within Tier 2 goal (210 days)	98.6%	100.0%	-	-	-
Tier 2 goal - Percent within 210 days	95%	95%	95%	95%	95%
Cohort status	Open	Open	-	-	-

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

 Real-time PMA Supplements

	FY 2008	FY 2009	FY 2010	FY 2011	FY 2012
Workload (Filed to Date)	248	167	-	-	-
Total FDA Decisions	238	108	-	-	-
Percent within Tier 1 goal (60 days)	96.6%	100.0%	-	-	-
Tier 1 goal - Percent within 60 days	80%	80%	80%	80%	80%
Percent within Tier 2 goal (90 days)	98.3%	100.0%	-	-	-
Tier 2 goal - Percent within 90 days	90%	90%	90%	90%	90%
Cohort status	Open	Open	-	-	-

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

 510(k)s

	FY 2008	FY 2009	FY 2010	FY 2011	FY 2012
Workload (Filed to Date)	3,848	1,925	-	-	-
MDUFMA Cohort	3,395	1,873	-	-	-
Total FDA Decisions	3,082	690
Percent within Tier 1 goal (90 days)	95.5%	98.3%	-	-	-
Tier 1 goal - Percent within 90 days	90%	90%	90%	90%	90%
Percent within Tier 2 goal (150 days)	99.4%	100.0%	-	-	-
Tier 2 goal - Percent within 150 days	98%	98%	98%	98%	98%
Cohort status	Open	Open	-	-	-

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

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

	FY 2003	FY 2004	FY 2005	FY 2006	FY 2007	FY 2008
Receipts	4,225	3,632	3,650	3,853	3,656	3,848
SE and NSE Decisions	3,741	3,310	3,344	3,447	3,147	3,106
NSE	122	121	133	144	129	117
% of all decisions	3.3%	3.7%	4.0%	4.2%	4.1%	3.8%
% of all outcomes	2.9%	3.3%	3.6%	3.7%	3.5%	3.3%
SE	3,619	3,189	3,211	3,303	3,045	2,989
% of all decisions	96.7%	96.3%	96.0%	95.8%	95.9%	96.2%
% of all outcomes	85.7%	87.8%	88.0%	85.8%	83.7%	83.7%
Other Outcomes	484	322	305	404	466	463
% of all outcomes	11.5%	8.9%	8.4%	10.5%	12.8%	13.0%
All Outcomes	4,225	3,632	3,649	3,851	3,640	3,569
Still pending	0	0	1	2	16	279
% of receipts	0.0%	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 2003	FY 2004	FY 2005	FY 2006	FY 2007	FY 2008
Receipts	193	195	196	291	265	249
FDA Decisions	190	183	190	274	259	240
"Not Approvalable"	6	9	9	15	12	23
% of all decisions	3.2%	4.9%	4.7%	5.5%	4.6%	9.6%
% of all outcomes	3.1%	4.6%	4.6%	5.2%	4.5%	9.3%
Other Outcomes	3	12	6	16	5	8
% of all outcomes	1.6%	6.2%	3.1%	5.5%	1.9%	3.2%
All Outcomes	193	195	196	290	264	248
Still Pending	0	0	0	1	1	1
% of all outcomes	0.0%	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 Received	673	170
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 Days	MFG Days	Total
APPR - Approved	61	0	61
APPR - Approved	248	38	286
APPR - Approved	248	38	286
APPR - Approved	398	0	398
APPR - Approved	398	0	398
Average Time for Approvals	271	15	286
DENY - Denied	56	0	56
DENY - Denied	102	0	102
DENY - Denied	129	0	129
DENY - Denied	189	0	189
DENY - Denied	199	0	199
DENY - Denied	287	0	287
Average Time for Denials	160	0	160
Average Time for All Decisions	210	7	217

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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 Establishments				Foreign Establishments
Rank	Establishment Type	Class I	Class II	Class III	Total	Class I	Class II	Class III	Total	Total Registered Establishments
Establishments Subject to MDUFA Registration Fee
1	Manufacturer	1,588	2,690	380	4,658	3,068	2,626	210	5,904	10,562
2	Contract Manufacturer	118	155	24	297	271	275	25	571	868
3	Contract Sterilizer	9	6	0	15	14	7	0	21	36
4	Specification Developer	519	665	62	1,246	101	139	6	246	1,492
5	Reprocessor of Single-Use Devices	2	12	0	14	1	0	0	1	15
6	U.S. Manufacturer of Export-Only Devices	7	25	30	62	0	0	0	0	62
Total, Subject to MDUFMA Fee		2,243	3,553	496	6,292	3,455	3,047	241	6,743	13,035
Establishments Not Subject to MDUFA Registration Fee
7	Repackager / Relabeler	560	377	27	964	168	62	3	233	1,197
8	Remanufacturer	17	26	0	43	24	8	0	32	75
9	Foreign Exporter				0	503	156	11	670	670
10	Initial Distributor / Importer				3,622				0	3,622
11	Unknown				86				62	148
Total, Not Subject to MDUFMA Fee		577	403	27	4,715	695	226	14	997	5,712
All Registered Establishments
Total, All Registered Establishments		2,820	3,956	523	11,007	4,150	3,273	255	7,740	18,747

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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

• * 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

 FY 2009 Medical Device User Fee Collections
As of March 31, 2009

Source	FY 2009 Authorized 1	Expected to Date 2	FY 2009 Fee Revenues					FY 2009 Surplus (Deficit)
			Receipts	Refunds	Net	% of Authorized	% of Expected	cf. Authorized	cf. Expected
Establishment Registration Fees	$23,600,250	$23,600,250	$26,009,389	$251,157	$25,758,232	109.1%	109.1%	$2,157,982	$2,157,982
Application / Reporting Fees	$28,946,750	$14,473,375	$17,186,073	$92,123	$17,092,950	59.0%	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	$43,165,968	82.1%	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 31	March 31	June 30	September 30
Establishment Registration Fees	100%	100%	100%	100%
APPR - Approved	25%	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 2003	FY 2004	FY 2005	FY 2006 30	FY 2007	FY 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:

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 Courses	Total# of Participants	Examples of Training Conducted/Attended Between October 1, 2008- March 31, 2009
Regulatory and Law (LAW)	11	427	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)	81	825	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)	8	178	Situational Leadership FDA Human Resources Management for  Supervisors Team of Rivals Effective Presentation Skills
Professional Development	37	674	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
TOTAL	87	2104

*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