# Presentation: 672771

## CDRH Scorecard Summary Through 4th Quarter FY 04 

**Robert Navazio 12/7/04**

**The “Yugo” version 1.3 **
**At a glance....**

## Summarize Center-Wide FY 04 data through 4th Quarter

Identify problems with data collection

Provide background to Executive Committee to make well informed decisions on FY 05 
scorecard indicators
performance targets

Discuss how we will use Center-Wide results to manage our programs in FY 05

- Identify problems with data collection
- Provide background to Executive Committee to make well informed decisions on FY 05
- scorecard indicators
- performance targets
- Discuss how we will use Center-Wide results to manage our programs in FY 05

**Purpose of Presentation**

## Are We Meeting our Targets? (Have we set targets?)

**Are We Meeting our Targets? ****(Have we set targets?)**

- KRA 1 :**Public Health Promotion**

**Y**

- KRA 6: **Strategic Direction**

- KRA 2: **Public Health Protection**

- KRA 3: **Risk Mgmt Operational**
** ****Accountability**

- KRA 4: **Stakeholder Collaboration**

- KRA 5: **Workforce Excellence**

*Green: **	****Meeting Targets: ******	****No review (drill down) needed*
*   **Yellow: ****Not Meeting all ******	******Targets:**** Need to **	**review (drill down)*
*   **Red: **	****More than X% of      ******	******measures not meeting ******	******targets**** (need to review **	**	**(drill down)*
*   **White: ****Need to work on ******	******setting the right ******	******measures and/or targets***

**Y**

**W**

**W**

**W**

**W**

## Keep in Mind (What gets measured gets done!)

- Measures: the fewer the better -- with indices
- Measures should be intermediate outcome based whenever possible (not only output based)
- Measures should be focused on key factors needed for success
- Measures should be integrated at all levels of the organization
- Measures need to have targets from baseline data rather than arbitrary numbers

## KRA 1: Public Health Promotion

| Application Type | FY 99-01 Baseline
Median Total Time | FY 04 
Median Total Time | Number 
Met Goal | Number Not Met Goal |
| --- | --- | --- | --- | --- |
| HDE Originals
1/6 = 17% | 164 | 228 | 1 | 5 |
| Expedited PMA Originals
4/5 = 80% | 482 | 294 | 4 | 1 |
| Expedited PMA Panel Track Supplements
1/1= 100% | 386 | 169 | 1 | 1 |

- Target: 50% or more approved or cleared expedited PMA’s, expedited PMA panel track
- Supplements, expedited 510 (k)s, and original HDE’s; will have less total elapsed time
- than FY 99-01 median baseline for each application

- 1A CDRH Timely access to novel, expedited products rating
- Total Elapsed Time FY 04 Totals

**KRA 1: Public Health Promotion**

**Y**

## % of IDE originals approved in first 30 day cycle

- 1B CDRH Pre-Approval access index FY 04 Totals

**KRA 1: Public Health Promotion**

**Need**
**a**
**Target?**

**Baseline**

**N= 224**

## KRA 1: Public Health Promotion

**KRA 1: Public Health Promotion**
**KRA 3: Risk Management ****(non-expedited)**

- _Note:_ Review consult data on this slide was reported by OSB, OCER, OSEL and OC and should be included in their FY 05 Office scorecards.

_**On-Time Review Consults**_
**Expedited Review Consults = 96% (44/46)**
**Pre-IDE & IDE Review Consults = 99% (629/636) **
**Non-Expedited Review Consults = 98% (2,189/2,227)**

**FY 05**
**Target**
**90%?**

## 2A CDRH Problem Timeliness Rating

Data was not reported because of inconsistent definitions

OSB has the lead to recommend better measures

- Data was not reported because of inconsistent definitions
- OSB has the lead to recommend better measures

**KRA 2: Public Health Protection**

**W**

## KRA 3: Risk Management

**Expedited PMA**
**Panel Track Supplements **

**G**

**KRA 3: Risk Management**
** ****Operational Accountability**

**Original PMA**
**Panel Track Supplements**

**G**

**180 Day Supplements**
** **

**G**

- Overview of 3A CDRH Application Review Timeliness Index
**FY 03 & FY 04**

**510(k)s**

**G**

**Y**

**FY 04 Performance **
**Summary**

**Y**

**Cycle goals (FY 03)**

**G**

**Cycle goals (FY 04)**

*Green: **	**meeting targets: no drill down needed*
*Yellow: not meeting all targets: need to drill down to next level*

## KRA 3: Risk Management 

**           ****MDUFMA Cohort Closed 100%**

- 3A CDRH Application Review Timeliness Index
- FY 03 expedited PMA’s as of 9/30/2004

**FY 05 **
**Target 70%**

**3 Expedited PMAs**
** ****received and filed**
**Cohort Closed**

**KRA 3: Risk Management **
**Operational Accountability**

**G**

**FY 05 **
**Target 70%**

**70%**

## KRA 3: Risk Management 

**           ****Best Case 95%**

- 3A CDRH Application Review Timeliness Index
- FY 03 Original PMAs (as of 9/30/04)

**47 received and filed, **
**6 awaiting **
**MDUFMA Decision**

**FY 05 **
**Target 80%**

**Worst Case:**
**83%**

**% of MDUFMA On-Time Decisions**

**KRA 3: Risk Management **
**Operational Accountability**

**G**

**80%**

## KRA 3: Risk Management 

**% of On- Time MDUFMA decisions**

**FY 05 Target 80%**

- 3A CDRH Application Review Timeliness Index
- FY 03 180 Day Supplements (as of 9/30/04)

**203 received **
**Cohort Closed**

**Cohort Closed: 94%**

**KRA 3: Risk Management **
**Operational Accountability**

**G**

**80%**

## KRA 3: Risk Management 

**Worst Case 75%**
**Best Case 76%**

- 3A FY 03 Application Review Timeliness Index
- FY 03 510(K)s (as of 9/30/04)

**3,772 in MDUFMA**
** ****Cohort, 66 awaiting **
**MDUFMA Decision**

**KRA 3: Risk Management **
**Operational Accountability**

**FY 05 Target 75%**

**G**

**75%**

## KRA 3: Risk Management 

| Applications | Best Case | Worst Case |
| --- | --- | --- |
| Expedited PMAs+ 
Panel Track Supplements | 100%
 | 29% |
| Original PMAs+ Panel Track Supplements | 100% | 25% |
| 180 Day PMA Supplements | 98% | 60% |
| 510(k)s | 89% | 63% |

- FY 04 Receipt MDUFMA Cohort Decision Goal Performance Summary
- (as of 9/30/2004)

**KRA 3: Risk Management **
**Operational Accountability**

**Y**

## KRA 3: Risk Management 

| Sample Cycle Goals | Review Time Target | FY 03 Receipt Cohort Performance 
(as of 9/30/04) | FY 05 Target |
| --- | --- | --- | --- |
| Expedited PMA and Panel Track Supplement First Action- 
Major Deficiency Letter  | 120 days
 | 2 Actions, 2 on time
100% of actions on time | 70%
 |
| Standard PMA and Panel Track Supplement First Action- 
Major Deficiency Letter  | 150 days | 25 Actions, 21 on time
84% of actions on time | 75% |
| 180 Day PMA Suppl. First action:
Not Approvable

All other first actions | 
120 days 

180 days

 | 
31 actions, 5 on time
16% of actions on time
172 Actions, 164 on time
95% of actions on time | 
80%

80% |
| 510k- First action – “additional information” letter | 75 days | 1,694 Actions, 980 on time
58% of actions on time | 70% |

**Performance Updates for Selected MDUFMA Cycle Goals with CDRH Data FY 03 Receipt Cohort **
**(as of 9/30/04)**

**KRA 3: Risk Management **
**Operational Accountability**

**Y**

- Page # 15

## KRA 3: Risk Management 

| Sample Cycle Goals | Review Time Standard | FY 04 Receipt Cohort Performance 
(as of 6/30/04) | FY 05 Target |
| --- | --- | --- | --- |
| Expedited PMA and Panel Track Supplement First Action- 
Major Deficiency Letter  | 120 days | 9 Actions, 7 on time
78% of actions on time | 70%
 |
| Standard PMA and Panel Track Supplement First Action- 
Major Deficiency Letter  | 150 days
 | 20 Actions, 17 on time
85% of actions on time | 75% |
| 180 Day PMA Suppl. First action: Not Approvable

All other First Actions | 
120 days

180 days | 
24 actions, 21 on time
87% of actions on time
40 Actions, 39 on time
97% of actions on time | 
80%

80% |
| 510k- First action – “additional information” letter | 75 days | 1,355 Actions, 1,063 on time
78% of actions on time
 | 70% |

**Performance Updates for Selected MDUFMA Cycle Goals **
**with CDRH Data FY 04 Receipt Cohorts (as of 9/30/04)**

**KRA 3: Risk Management **
**Operational Accountability**

- Page # 16

**G**

## KRA 3: Risk Management 

- OCER reported 2.1% cumulative annual inspections where the highest observation is repeat Level 1or Level 1, compared to an FY 03 baseline of 2.1%
- ODE reported 38 SE with limitation letters in FY 04, compared to 34 in FY 03
- OSEL reported 51 postmarket consults
- OSEL reported 2,065 calibrations in FY 04
- OIVD processed recalls in 9 average calendar days

**KRA 3: Risk Management **
**Operational Accountability**

**W**

## CDRH hired 130 of 152 MDUFMA hires approved for FY 03 + FY 04 (85% over two year period)
Financial managers throughout the Center made regular reports on payroll and operating expenditures, staffing gains and losses, and cash awards. Senior Staff decisions are still pending on which of these financial management indicators to include in the Center scorecard.

- Financial managers throughout the Center made regular reports on payroll and operating expenditures, staffing gains and losses, and cash awards. Senior Staff decisions are still pending on which of these financial management indicators to include in the Center scorecard.

**3D CDRH Business Accountability Index (Fourth quarter hires as of 10/2/04)**

**KRA 3: Risk Management **
**Operational Accountability**

**W**

## 853 Meetings with Industry (What’s the FY 05 target?) 

Customer Perception Survey: 79% of the 274  application sponsors had a positive perception of CDRH review programs (What’s the target for our current survey based on FY 04 applicants?)

Based on the survey results, CDRH’s future goal is to improve efforts relating to guidance and standards development (How did we do last survey? 77% positive  responses about guidance/standards posted on the Web)

- Customer Perception Survey: 79% of the 274  application sponsors had a positive perception of CDRH review programs (What’s the target for our current survey based on FY 04 applicants?)
- Based on the survey results, CDRH’s future goal is to improve efforts relating to guidance and standards development (How did we do last survey? 77% positive  responses about guidance/standards posted on the Web)

- 4A  CDRH Industry Collaboration Level, FY 04

**KRA 4: Stakeholder Collaboration**

**W**

## KRA 4: Stakeholder Collaboration

**Add the following to Center Scorecard Indicators:**

- % of high priority guidances CDRH approves and sends to FDA (need FY 05 target)
- % of high priority review standards CDRH recognizes for review (need FY 05 target)

**KRA 4: Stakeholder Collaboration**

**W**

## KRA 4: Stakeholder Collaboration

** ****relevance and updated **

- 4B CDRH better informed consumers and other stakeholders rating proposal

- Center Decisions needed to focus on major current outreach areas in each office like
- % of current major internet sites updated
- % completion for major new internet sites like the pediatric site or other new
-  outreach initiatives

**Current major internet sites include:**
**MQSA site**
**Diabetes site **
**Lasik site**
**Cardiovascular health site**

**KRA 4: Stakeholder Collaboration**

**FY 2005 Target 65%?**

**65%**

**W**

## KRA 5: Workforce Excellence

**Staff College Data**
**(Includes Staff College programs**
**and training where “350” forms were done)**

**Time Reporting Data**

**         **** ****?  **** **
**FY04 Target**

- 5A Science based Regulatory Expertise level, Internal and External Average Hours of Training Per Employee Per Year, 4th Quarter FY 04

- FY03 Baseline

**FY04 **
**1****st**** Quarter**
**Projection**

**Average Hours of Training Per Employee Per Year**

**FY04**
** ****2****nd**** Quarter**
**Projection**

**FY04 **
**3****rd**** Quarter **
**Projection**

**Hours**

**FY04 **
**Cumulative ****Total**

**KRA 5: Workforce Excellence**

**W**

## KRA 5: Workforce Excellence

- 5A CDRH Science-based Regulatory Expertise Level, Internal and External
- Expertise Dollars Fourth** **Quarter FY 04 :

-    External
-   Expertise
-    Dollars
-  In Millions

**FY 04 Target 14.5M**

- External expertise investments include contracts and fellowships to supplement
- CDRH internal expertise.  It does not include routine activities like document control,
- animal care and scanning.  CDRH’s Strategic Plan Phase II goal was to increase
- this by 10% in FY 04

**KRA 5: Workforce Excellence**

**W**

**FY 05 Target ?**

## 
OCER reports 51% (15/29) of accredited third parties are international

OSEL reports cumulative level of 35% (246/ 695) of standards recognized are international

ODE reports 4% (5 of 130) of abbreviated 510(k)s used recognized international standards

- OCER reports 51% (15/29) of accredited third parties are international
- OSEL reports cumulative level of 35% (246/ 695) of standards recognized are international
- ODE reports 4% (5 of 130) of abbreviated 510(k)s used recognized international standards

**KRA 6: Strategic Direction**

- 6B CDRH Globalization Index,4th Quarter FY 04

**W**