# Presentation: 668947

## CBER

**CBER**
**MDUFMA Activity**** **

- Leonard Wilson
- Review Management
- Center for Biologics Evaluation and Research

**MDUFMA Stakeholder Meeting**
**November 18, 2004**

## MDUFMA Implementation

- Harmonization with CDRH Continues
- Participation on all MDUFMA Committees
- MDUFMA guidances issued as joint documents by CDRH and CBER
- Harmonization of review processes and procedures
- e.g. use of CDRH “blue book” memos as interim general reviewer guidance pending development of appropriate CBER SOP’s
- Device Review Subcommittee of RMCC
- Management initiatives in OBRR

## CBER DEVICE FTEs

|  | FY 02 | FY 03 | FY 04 |
| --- | --- | --- | --- |
| MDUFMA | 47 | 60 | 67 |
| Other Device | 9 | 9 | 8 |
| Total | 56 | 69 | 75 |

## Preliminary FY03 510k Performance

|  | FY03 Performance | FY05 Goal |
| --- | --- | --- |
| Final decision <90 days | 100% | 75% |
| First action <75 days | 100% | 70% |
| Second action < 60 days | 100% | 70% |

**10% of cohort awaiting final decision as of 10/31/04**

- Performance may decrease with completion of pending submissions.

## Preliminary FY04 510k Performance

|  | FY04 Performance | FY05 Goal |
| --- | --- | --- |
| Final decision <90 days | 98% | 75% |
| First action <75 days | 89% | 70% |
| Second action < 60 days | 100% | 70% |

**11% of cohort awaiting final decision as of 10/31/04**

- Performance may decrease with completion of pending submissions.

## Preliminary FY03 PMA Performance

|  | FY04 Performance | FY05 Goal |
| --- | --- | --- |
| Final decision <320 days | 100% (n=2) |  None |
| First action: Major
Deficiency Letter
<150 days | 100% (n=1) |  75% |
| First action: All Other Letters (Approval, Approvable, NA,  denial, etc.)
<180 days | 100% (n=2) |  75% |

**33% of cohort awaiting final decision as of 10/31/04**

- Performance may decrease with completion of pending submissions.

## Preliminary FY04 PMA Performance

|  | FY04 Performance | FY05 Goal |
| --- | --- | --- |
| Final decision <320 days | Pending (n=1) |  None |
| First action: Major
Deficiency Letter
<150 days | Pending (n=1) |  75% |
| First action: All Other Letters (Approval, Approvable, NA,  denial, etc.)
<180 days | Pending (n=1) |  75% |

**100% of cohort awaiting final decision as of 10/31/04**

- Performance may decrease with completion of pending submissions.

## FY03 BLA Performance

|  | FY03 Performance | FY05/06 Goal |
| --- | --- | --- |
| Review/act <10 months | n=0 | 75% |
| Class 2 resub. <6 months | 100% | 75% |
| Prior Approval sup. < 4 months | 99% | 75% |

## Preliminary FY04 BLA Performance

|  | FY04 Performance | FY05/06 Goal |
| --- | --- | --- |
| Review/act <10 months | 88% 1 complete
         8 pending | 75% |
| Class 2 resub. <6 months | 80%      | 75% |
| Prior approval sup. < 4 months | 100%       27%
             pending | 75% |

## What improvements led to better performance ?

- Better management
- Focus on problem solving in-cycle
- Supervisor and Reviewer training
- Document handling further improves (e-submissions too!)
- CBER/CDRH 3rd annual Best Practices workshop

## MDUFMA FY 05

- Apply a Quality Systems approach to the Review Process
- CBER 510(k)s increasing
- Systematic management of time frames (cycle strategy)
- Mid cycle meeting
- Increased electronic submissions