# Presentation: 672772

## Premarket Review Performance Goals

**Donna-Bea Tillman**
-  Director, Office of Device Evaluation
**Don St. Pierre**
- Deputy Director, Office of In Vitro Diagnostic Device Evaluation and Safety

- MDUFMA Stakeholder Meeting
- November 18, 2004

## MDUFMA’s Promise

-    FDA will turn dollars into shorter review times.

## MDUFMA’s Challenge

## How are we making this happen?

## New Vision of Pre-Market Review

**Office of Device Evaluation**

**Office of**
** ****Surveillance **
**& Biometrics**

**Office of Science & Engineering Laboratories**

**Office **
**of **
**Compliance**

**Office of Communication, Education, and Radiation Programs**

**Office of In Vitro Diagnostic Device Evaluation and Safety**

**Office of  Management Operations**

## What are we doing to foster this vision?

- Shared hires
- eRoom
- eConsults
- Shared agreement on timelines.....

***-> Shared commitment to the goals***

## How are we spending your money?

## Hiring!

## CDRH Device Review Process FTEs

**Light Blue -- ****Other MDUFMA Review Process FTEs:****  **Adverse Exp. Reporting,
- Lab Based Studies,  Problem ID Resolution, Science Based Training, Domestic Standards,
- and Postmarket Studies.
**Red -- ****Premarket FTEs: **Application Review**, **Guidance and Standards,
- Bioresearch monitoring and Manufacturers assistance.

## CDRH Device Review FTEs by Category

**9**

**28**

**45**

**8**

**12**

**12**

**15**

**1**

- Physicians* - 15
- Visiting Scholar – senior level clinicians, surgeons
- Fellow -  physician during fellowship training
- Resident – physician during residency training
- Engineers* - 42
- Visiting Scholar – senior level engineer
- Co-op students
- Interns
- Physicists* - 2
- 		*includes students

- Medical Device Fellowship Program (FY04)

## All those new hires need to be trained
The good news: training for new recruits improved their proficiency
The bad news: training for new recruits took a lot of resources and is not complete.  
We also need to maintain the skills of existing staff

- The good news: training for new recruits improved their proficiency
- The bad news: training for new recruits took a lot of resources and is not complete.
- We also need to maintain the skills of existing staff

- Training!

## Improved IT infrastructure!

- Current IT needs
- Tracking
- Reviewing
- Collaborating
- Managing correspondence
- Archiving - Image

**Electronic Review?**

- And maybe one day....

## Just the Numbers

**For complete report, please see:**
**http://www.fda.gov/cdrh/mdufma/presentations/102004-kahan.ppt**

## Status of FY03 PMA/O & PT-PMA/S receipt cohort 

- Status of FY03 PMA/O & PT-PMA/S receipt cohort

- Complete

- In Process

- (August 18, 2004)

***100% of those with final decisions completed in     < 320 days***

## CDRHPMA PerformanceFY 2003 Receipt Cohort as of 9/30/2004

- 47 Original PMAs and P-T Supplements filed
- 41 FDA decisions; 6 pending applications
- % of decisions meeting goal:  95%
- % of cohort meeting goal (to date):  83%
- % awaiting MDUFMA decision:  13%
- FY 2006 Goal:  80% of FDA decisions within 320 FDA days
-   (Decision = approval, approvable, approvable pending GMP, not approvable, denial)

## CDRHPMA PerformanceFY 2003 Receipt Cohort as of 9/30/2004

- 25 1st action = major deficiency letter
- % of actions meeting goal:  84%
- 		FY 2005 Goal: 75% within 150 FDA days
- 22 “all other” 1st actions
- % actions meeting goal:  96%
- 		FY 2005 Goal: 75% 180 FDA days
- FY 2003 first action cohort is *closed*

## Status of FY04 PMA/O & PT-PMA/S receipt cohort 

- Status of FY04 PMA/O & PT-PMA/S receipt cohort

- Complete

- In Process

- (August 18, 2004)

***100% of those with final decisions completed in < 320 days***

## CDRHPMA PerformanceFY 2004 Receipt Cohort as of 9/30/2004

- 41 Original PMAs and P-T Supplements filed
- 11 FDA decisions; 30 pending applications
- % of decisions meeting goal:  100%
- % of cohort meeting goal (to date):  27%
- % awaiting MDUFMA decision:  73%
- FY 2006 Goal:  80% of FDA decisions within 320 FDA days
-   (Decision = approval, approvable, approvable pending GMP, not approvable, denial)

## CDRHPMA PerformanceFY 2004 Receipt Cohort as of 9/30/2004

- 20 1st action = major deficiency letter
- % of actions meeting goal:  85%
- 		FY 2005 Goal: 75% within 150 FDA days
- 12 “all other” 1st actions
- % actions meeting goal:  100%
- 		FY 2005 Goal: 75% 180 FDA days
- 9 with first action pending (22% of cohort)

## Improving PMA performance

- Goal: Shorten both cycle and total decision times

- ... which will improve predictability and decrease time-to-market.

## Original PMA Milestones:1-cycle Scenario

- Filing Review

**Scientific Review**

**Panel Planning**

**Closeout Review**

**PMA Received`**

**Panel **
**Go/NoGo**

**Panel Meeting**

**Filing Letter**

**Final Decision**

**180 days**

**Status**
**Letter**

**Consults Complete**

**Interactive Review**

## Original PMA Milestones:2-cycle Scenario

- Filing Rev

**Scientific Review**

**Panel Planning**

**Closeout Review**

**PMA Received**

**Panel Go/NoGo**

**Panel Meeting**

**Filing Letter**

**Final Decision**

**320 days**

**Major **
**Def. **
**Letter**

**Scientific Review**

***Clock Stops***

**Staus Letter**

**Interactive**
** ****Review**

**Consults Complete**

## 510k Goals

## FY03 510k Performance

|  | FY03 Performance | FY05 Goal |
| --- | --- | --- |
| Final decision <90 days | 76% | 75% |
| First action <75 days | 58% | 70% |
| Second action < 60 days | 50% | 70% |

- Need to improve performance on cycle goals

## Meeting the MDUFMA goals: Review Process for Traditional 510ks

- Meeting the MDUFMA goals: Review Process for Traditional 510ks

**Preliminary determination that no ****significant**** additional info needed**

**FDA Initial Review**

**Interactive Review**

***Final Decision ******(***_***<***_***90 total days)***

***Scenario #1***

## Meeting the MDUFMA goals: Review Process for Traditional 510ks

**FDA Initial Review**

**Interactive Review **

**Determination that  significant additional info needed**

***Hold ***

***Final Decision ******(***_***<***_***90 total days)***

***Scenario #2***

**Preliminary determination that no ****significant**** additional info needed**

## Meeting the MDUFMA goals: Review Process for Traditional 510ks

**FDA Initial Review**

** ****Review **

**Determination that  significant additional info needed**

***Hold***

***Final Decision ******(***_***<***_***90 total days)***

***Scenario #3***

***Hold***

** ****Review **

**Determination that  significant additional info needed**

## Preliminary FY04 510k Performance

|  | FY04 Performance | FY05 Goal |
| --- | --- | --- |
| Final decision <90 days | 89% | 75% |
| First action <75 days | 78% | 70% |
| Second action < 60 days | 81% | 70% |

- Preliminary data suggests improvement in performance on cycle goals

**29% of cohort awaiting final decision as of 9/30/04**

## What about the Science?

## Program to Assess Quality of Premarket Reviews

- Focuses on selected cross-cutting areas (e.g., biocompatibility)
- Retrospective (post-decision) peer assessments of sampled reviews
- Quality assessment teams with defined criteria
- Pilot underway

## Where have we been?

- We’ve made progress in meeting the goals, but it has come at a price.

## The price of early success

- Our staff are working at the limits of their abilities
- “Luxuries” such as training, standards, and guidance development have been neglected

## Where are we now?

- We’ll continue to improve performance, but there are additional challenges ahead.

## The number of combination products is growing...

*Drug-eluting*

*Steroid-eluting*

- Coronary Stent

- Pacing Lead

*rhBMP*

- Bone graft

- ... necessitating new kinds of technical expertise and new regulatory paradigms.

## The number of 510ks with clinical data is growing...

**Embolic protection devices**

- ... requiring more in-depth review, including occasional Panel input.

**Vascular anastomsis devices for CABG**

- Image-guided bronchoscopes

**Barbed sutures**

- Glaucoma shunts

***Daily wear contact lenses***

***CPAP devices for apnea***

## The number of expedited submissions is growing....

- expedited PMAs in FYO4

- vs.

- 3 expedited PMAs in FYO3

- 14

- ... shortening timeframes and bringing increasingly complex scientific questions.

## Where are we going?

- The best is yet to come!

## Strategies for Meeting Beating the MDUFMA Goals

- Improvements to IT infrastructure
- Well-trained staff
- More guidance documents
- Open communication

- Strategies for Meeting Beating the MDUFMA Goals

## The REAL promise of MDUFMA

- More interaction
- Stronger science
- Greater predictability
- Better public health

## ...and a continuing commitment to Least Burdensome Principles

## Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

- Turbo 510(k) Pilot
- Software/program development
- Pre-IDEs
- Number/interactions increasing
- Decision Summaries
- Public/information sharing
- Webpage Re-design in process
- Based on your feedback
- Internal training (challenging the status quo)
- Stressing TPLC, Communication, Collaboration

## Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

- Also, Proactive in:
- Bioterrorism activities to improve development and access to rapid diagnostics
- CLIA improvements (including development of waiver criteria, program development)
- Pharmacogenomics

## Questions?

**MDUFMA**

**Questions?**