# Presentation: 737088

## CDRH: Moving Forward 

- Elizabeth D. Jacobson, Ph.D.
- Deputy Director for Science
- Center for Devices and Radiological Health
*Phoenix, AZ, March 23, 2000*

## CDRH -- Moving forward

- Past
- Budget
- Performance
- Present
- Least burdensome path to market
- Dispute resolution and ombudsman
- “Inreach” to CDRH
- CDRH and HIMA
- Future

## Appropriations for FY 2000 

- Allocates $114 to CDRH  & 40 M to field for CDRH activities, mandating:
- $7.0 million increase for device review
- $3.7 million pay raise
- Use of $1 million for reprocessed devices -- premarket review, enforcement, oversight
- Allocation of no less than $55.5 million and        522 FTEs by whole agency for device review   to meet statutory timeframes

## Device FTE History

**76**

**77**

**78**

**79**

**80**

**81**

**82**

**83**

**84**

**85**

**86**

**87**

**88**

**89**

**90**

**91**

**92**

**93**

**94**

**95**

**96**

**97**

**98***

**99***

**0**

**250**

**500**

**750**

**1000**

**Medical Devices**

**Radiological Health**

**Mammography Act**

**Med. Dev. Amend.**

**Merger of BRH & BMD**

**MQSA**

**Fiscal Year**

**SMDA**

**FDAMA**

**Device FTE History**
**Fiscal Years 1976 - 1999***

## Performance:510(k)s - Alternatives	

**108**

**4,155**

- Traditional

**29**

**361**

- Special

**99**

**75**

- Abbreviated

- Average Total
- Time (days)

- Reviews
- Completed
- FY99

## Disappointing review times?Abbreviated 510(k)s	

- New guidance will help.   See: _http://www.fda.gov/cdrh/ode/guidance/1131.html_ Manufacturers may submit:
- A declaration of conformity to a recognized standard
- A statement that product will conform to a recognized standard when finally marketed
- A statement that the product will conform to a non-recognized standard  -- decided case-by-case
- Standards development is key

## Performance:510(k)s - Third party review	

- 154 device types eligible - mostly class II
- Represents 1200 eligible 510(k)s / yr
- Only 32  submitted to 3rd parties in FY 99
- Comparison of total elapsed review time:		                                                                              510(k)s with 3rd party review -     	      57 days                                           Comparable 510(k)s(all FDA review) - 105 days
**Plans for expansion**

## Performance:  PMA and PMA Supplement Total Review Times

## Pre-PMA & Pre-IDE Meetings	

- 24 pre-IDE      12 pre-PMA        3 both
- CDRH gets very few requests
- Center policy:  each firm limited to
**one determination meeting **
**one agreement meeting**
- CDRH requests that companies bring detailed, comprehensive info and allocate enough time        to produce an agreement where possible

## GMP Domestic InspectionsFY 96 - FY 99

**No. of Inspections**

**1846**

**1357**

**1187**

**1028**

## 1999 Device Inspections

**State**
**MQSA**
**Inspections**

**FDA**
**Total**

**FDA**
**MQSA**

**GMP**

**BIMO**

**Pre Approval**

**Other**

## Least Burdensome Path to Market 

- Interpretation
- Goal:  To get the right information to support submissions -- not more, not less
- Data:  Needed and appropriate to product
- Process:  Interactive and transparent

## Least Burdensome Path to Market (cont.)

- Implementation
- Public comments via Jan. 1999 meeting with stakeholders
- Proposal from LB Industry Task Force
- Comments via docket, letters, discussions
- Draft guidance released 9/1/1999
- Focus is clinical data requirements

## Least Burdensome Path to Market(cont.)

- Implementation (cont.)
**Small working group of FDA & industry task force now meeting to draft:**
**Statement of concept and general principles**
**Algorithm for least burdensome approach**
**LB webpage on Center’s FDAMA website**
_**http://www.fda.gov/cdrh/modact/leastburdensome.html**_
**Public meeting or teleconf. this summer**

## Least Burdensome Path to Market(cont.)

- Implementation (cont.)
**Training classes for CDRH review staff**
**includes industry comments, videotape**
**Training for advisory committee panels**
**Adding language to correspondence with industry to raise least burdensome concerns**

## Dispute Resolution

- FDAMA - §404
- Dispute resolution panel chartered
- Announced recruitment for panel members - Nov. 99
- Hope to begin impaneling members in  Spring
- CDRH’s current track record :
- Of 77 competed appeals, CDRH reversed its decision in whole or in part 40% of the time.
- Recruited ombudsman

## Ombudsman

- Disputes and common problem areas
- Reports directly to the Center Director
- Outreach
- Follow-up
- Quality Systems relating to common 	problem areas

## Ombudsman

- Les Weinstein
- BA Poly Sci, MPA, JD
- HHS:  Medicaid programs, HMOs
- CDRH: Regulations, FOI, International areas
- FDA (agency level):  Deputy Dir., FOI Staff;                       Denials & Appeals Officer
- Adjunct Prof., MC; member of DC Bar

## “Inreach” Using the Web

- Industry and consumer feedback
- Device Advice comment line:  dsma@cdrh.fda.gov
- E-mail:  Director@cdrh.fda.gov
- Opportunity for direct feedback via the Web
- “Comments”
- Commenting on proposed regulations electronically
- Postmarket Surveillance provision  (section 522)

## CDRH and HIMA

- Cooperation to accomplish mutual public health goals
- Least burdensome - part of small workgroup
- Ways to expand 3rd party review
- Commenting on document via Web
- Use of standards
- Device Industry/FDA Grassroots Committee

## CDRH and HIMA (cont.)

- Global Harmonization Task Force
- HIMA and FDA participating together since inception
- IVD Roundtable - Industry/FDA group focusing on
- IVD issues and common interests for collaboration
- Improved industry/FDA communication on IVD issues
- Postmarket surveillance of cardiovascular devices

## CDRH and HIMA (cont.)

- Reengineering
- Re-marketing/servicing - in AAMI working group developing voluntary approach for self-regulation
- Blood glucose monitors - potential CRADA to support study of two technologies
- Training

## Future

- What’s your wish list?