# Presentation: 740254

## David W. Feigal, Jr., M.D., M.P,H,
Director, Center for Devices and Radiological Health

- Director, Center for Devices and Radiological Health

***FDLI April 2001***

## Submissions: Fiscal Year 2000 

- Submissions: Fiscal Year 2000

| PMA Original | 67 |
| --- | --- |
| PMA Supplements | 545 |
| IDE’s Original | 311 |
| IDE Amendments | 240 |
| IDE Supplements | 4388 |
| 510(k)s | 4202 |
| Humanitarian DE | 11 |
| HDE Supplements | 10 |
| “Minor” Submissions | 7145  |
| Total | 16919 |

- 65 Submissions per day

**Performance**

## PMA Total Approval Times

**Performance**

## 510(k) Decisions

**Performance**

## 510(k) Total Decision Times

**Performance**

## 510(k) Total Decision Times

- Not reached Yet

**Performance**

## Dispute Resolution:
Ombudsman:  Les Weinstein
Dispute Resolution Panel
Least Burdensome

- Dispute Resolution:
- Ombudsman:  Les Weinstein
- Dispute Resolution Panel
- Least Burdensome

**FDAMA Implementation**

## First Year Experience
Complaints:  24
Disputes:      11
Complaint about or Dispute with: (Some Complaints/Disputes were about more than one Office)
ODE:	23 (61%)
OC:  	  6 (18%)
Other: 9 (24%)
 About:	
 510(K): 18 (51%)
 PMA:      2 (6%)
 Registration & Listing:  2 (6%)
 Other:  13 (37%)

- Complaints:  24
- Disputes:      11
- Complaint about or Dispute with: (Some Complaints/Disputes were about more than one Office)
- ODE:	23 (61%)
- OC:  	  6 (18%)
- Other: 9 (24%)
-  About:
-  510(K): 18 (51%)
-  PMA:      2 (6%)
-  Registration & Listing:  2 (6%)
-  Other:  13 (37%)

**Ombudsman**

## First Year Experience
Complaints:  24
Disputes:      11
Complaint about or Dispute with: (Some Complaints/Disputes were about more than one Office)
ODE:	23 (61%)
OC:  	  6 (18%)
Other: 9 (24%)
 About:	
 510(K): 18 (51%)
 PMA:      2 (6%)
 Registration & Listing:  2 (6%)
 Other:  13 (37%)

- Complaints:  24
- Disputes:      11
- Complaint about or Dispute with: (Some Complaints/Disputes were about more than one Office)
- ODE:	23 (61%)
- OC:  	  6 (18%)
- Other: 9 (24%)
-  About:
-  510(K): 18 (51%)
-  PMA:      2 (6%)
-  Registration & Listing:  2 (6%)
-  Other:  13 (37%)

- If ODE:
- DRARD:  1     (4%)
- DCLD:    2      (9%)
- DGRND: 9   (39%)
- DDIGD:  5   (22%)
- DCRD:    6   (26%)
- DOED:   0      (0%)

**Ombudsman**

## Issues: (Some complaints/disputes had more than issue.)
Communication:  17 (23%)
Evidence Requirements (data, testing):  11 (15%) 
Timeliness:  10 (13%)
 Conflict of Interest, Bias, Retaliation:  5 (7%)
 Rudeness/Difficulty Working With:  5 (7%)
 Procedures:  5 (7%)
 Disclosure:  4 (5%)
 Level Playing Field:  3 (4%) 
 Competence:  2 (3%)
 Drug/Device:  2 (3%)
 Other:  11 (15%)

- Communication:  17 (23%)
- Evidence Requirements (data, testing):  11 (15%)
- Timeliness:  10 (13%)
-  Conflict of Interest, Bias, Retaliation:  5 (7%)
-  Rudeness/Difficulty Working With:  5 (7%)
-  Procedures:  5 (7%)
-  Disclosure:  4 (5%)
-  Level Playing Field:  3 (4%)
-  Competence:  2 (3%)
-  Drug/Device:  2 (3%)
-  Other:  11 (15%)

**Ombudsman**

## Outcome: 
Resolved and/or Satisfied:  18 (51%). 
  in industry’s favor 	15 (83%)
  in FDA’s  favor	  3 (17%)
Pending:  13 (37%)
Referred or Unknown:  4 (11%)

- Resolved and/or Satisfied:  18 (51%).
-   in industry’s favor 	15 (83%)
-   in FDA’s  favor	  3 (17%)
- Pending:  13 (37%)
- Referred or Unknown:  4 (11%)

**Ombudsman**

## Dispute Resolution Panel 
First Meeting October 1990
Orientation and Organizational Agenda
Second Meeting Summer 1991
First manufacturers request for an appeal
PMA application heard before an FDA panel with recommendation not to approve
New analyses to address concerns did not reverse FDA decision to concur with initial recommendation
Dispute Resolution Panel’s recommendation will decide the issue unless there are compelling public health issues to disagree.

- First Meeting October 1990
- Orientation and Organizational Agenda
- Second Meeting Summer 1991
- First manufacturers request for an appeal
- PMA application heard before an FDA panel with recommendation not to approve
- New analyses to address concerns did not reverse FDA decision to concur with initial recommendation
- Dispute Resolution Panel’s recommendation will decide the issue unless there are compelling public health issues to disagree.

**Ombudsman**

## Agreement Meetings
Determination Meetings
Pre-IDE Meetings
Real Time Review

- Agreement Meetings
- Determination Meetings
- Pre-IDE Meetings
- Real Time Review

**Working with FDA**

## Meetings

|  | 1998 | 1999 | 2000 | Total |
| --- | --- | --- | --- | --- |
| Agreement Meetings | 7 | 16 | 2 | 25 |
| Determination Meetings | 3 | 8 | 4 | 15 |
| 100 Day Meetings | 5 | 15 | 7 | 27 |
| Total | 10 | 24 | 6 | 67 |

| Pre IDE | 300 | 299 | 315 |
| --- | --- | --- | --- |

- (24 reached agreement)

- (14 reached agreement)

**Meetings**

## Meetings

- 315

- 299

- 300

- 106

|  | 1998 | 1999 | 2000 | Total |
| --- | --- | --- | --- | --- |
| Agreement Meetings | 7 | 16 | 2 | 25 |
| Determination Meetings | 3 | 8 | 4 | 15 |
| 100 Day Meetings | 5 | 15 | 7 | 27 |
| Total | 10 | 24 | 6 | 67 |

- (24 reached agreement)

- (14 reached agreement)

- 1997

- 1996

**Meetings**

## Real Time PMA Supplements
146 requests for Real-Time PMA Supplements 
Representing 27% of all PMA supplements
134 were approved
Most by telephone conference

- 146 requests for Real-Time PMA Supplements
- Representing 27% of all PMA supplements
- 134 were approved
- Most by telephone conference

**Meetings**

## Least Burdensome Path to Market

**Least Burdensome Path to Market**

## Ombudsman Survey
1.  In the meeting, were the least burdensome principles applied in determining the need for prospective data in the following:
Was pre-clinical testing considered in lieu of clinical data?  Yes:  2    No:  9
Was the use of previously collected non-US data, literature, and/or registry data considered? Yes:  5    No:  6

- 1.  In the meeting, were the least burdensome principles applied in determining the need for prospective data in the following:
- Was pre-clinical testing considered in lieu of clinical data?  Yes:  2    No:  9
- Was the use of previously collected non-US data, literature, and/or registry data considered? Yes:  5    No:  6

**Least Burdensome**

## Ombudsman Survey
2.      In the meeting, were the least burdensome principles applied in designing the clinical trial in the following:
Were alternatives to an actively controlled trial considered?   Yes:  5    No:  4   n/a: 1
     If yes, check the following:
          Literature control     		 Yes:  1  No:  3
          Historical control      		  Yes: 2   No:  3
          Non-active control    		  Yes:  1  No:  3
          Patients as their own control  	  Yes:  1  No:  3
          Objective Performance Criteria  Yes:  1 No:  3
          Other      			  Yes:  1  No:  3

- 2.      In the meeting, were the least burdensome principles applied in designing the clinical trial in the following:
- Were alternatives to an actively controlled trial considered?   Yes:  5    No:  4   n/a: 1
-      If yes, check the following:
-           Literature control     		 Yes:  1  No:  3
-           Historical control      		  Yes: 2   No:  3
-           Non-active control    		  Yes:  1  No:  3
-           Patients as their own control  	  Yes:  1  No:  3
-           Objective Performance Criteria  Yes:  1 No:  3
-           Other      			  Yes:  1  No:  3

**Least Burdensome**

## Ombudsman Survey   
Was the use of surrogate endpoints considered?    	Yes:  1  No:  8    	n/a:  1  
 Was a least burdensome approach considered in determining how the primary and secondary endpoints will be measured?      	Yes: 4    No:  3	n/a:  1
  Was early submission of the application considered?  That is, could the application be submitted after a mutually agreed to percentage of the patients had been followed for a pre-defined period of time?       	Yes:  3   No:  6	n/a:  1
 Was the role of post marketing information considered as a mechanism for reducing the premarket requirements?             	Yes:  2     No:  8
Were the least burdensome principles applied in other areas of the trial design not mentioned above?  Yes:  2     No:  6	n/a:  1 

- Was the use of surrogate endpoints considered?    	Yes:  1  No:  8    	n/a:  1
-  Was a least burdensome approach considered in determining how the primary and secondary endpoints will be measured?      	Yes: 4    No:  3	n/a:  1
-   Was early submission of the application considered?  That is, could the application be submitted after a mutually agreed to percentage of the patients had been followed for a pre-defined period of time?       	Yes:  3   No:  6	n/a:  1
-  Was the role of post marketing information considered as a mechanism for reducing the premarket requirements?             	Yes:  2     No:  8
- Were the least burdensome principles applied in other areas of the trial design not mentioned above?  Yes:  2     No:  6	n/a:  1

**Least Burdensome**

## Global Quality System Standards
Global Regulation
Global Scientific Leadership
Evidence Based Medicine

- Global Quality System Standards
- Global Regulation
- Global Scientific Leadership
- Evidence Based Medicine

**Global Markets - Global Standards**

## Global Harmonization	Task Force

- Next Meets:  October 11-16, 2001  Barcelona, Spain
- Four study groups:
- Regulatory Requirements / Premarket Review
- Device Vigilance / Post-Market Surveillance
- Quality System Requirements and Guidance
- Auditing
- www.ghtf.org

**Harmonization**

## International Standards Organizations

|  | ANSI | BSI | DIN | Centralized European |  |  | CDRH |
| --- | --- | --- | --- | --- | --- | --- | --- |
|  |  |  |  | CEN | CENLAC | ETSI |  |
| Budget
(Millions $) | 15 | 293 | 100 | 10 | 4 | 21 | 140 |
| Staff | 79 | 4000 | 1000 | 115 | 36 | 107 | 1200
Including field |
| Committees | 262 | 2888 | 4600 | 1844 | 387 | 64 |  |
| Standards | 14202 | 19129 | 24000 | 5131 | 2863 | 709 | 500
Recognized |

## Guidant Global Compliance

**# of **
**Inspections**
**all Guidant**
**locations**

**Inspections 1997-August 2000**

**Guidant**** ****Global Compliance**

**12**
**37**
**26**

*Courtesy Michael Gropp, Guidant*

## 2000 Device Inspections

**Resources**

## Device Establishment Inspections

**Device Establishment Inspections**

**3602**

**1841**

**Resources**

## Enforcement ActionMedical Devices and Radiological Health

- Fiscal Years

- * Prior to 1976 Injunctions and Prosecutions were combined

## Mission:

CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.

- Mission:
- CDRH promotes and protects the health of the public by ensuring the safety and effectiveness of medical devices and the safety of radiological products.

**CDRH’s Strategic Plan**

## Consumer Protection

- Safe experimentationPremarket safety Premarket effectivenessResearch Inspection

- Truthful promotionAdverse Event Reporting Postmarket studiesManufacturing Inspection

**Consumer Protection**

## CDRH Vision - Total Product Life Cycle

## CDRH Vision - Total Product Life Cycle

**The Pipeline**

## Slide 32

## Slide 33

## Center for Devices     and Radiological Health

*Strategic Goals*
- Total Product Life Cycle
- Magnet for Excellence
- Knowledge Management
- Meaningful Metrics

## Consumers increasingly independent
Direct to Consumer Sales
Directed Advertising
Internet
FDA Internet Site
Increase from 30 million to 45 million hits per month in the last 6 months
Some consumer brochures are downloaded a million times per year
Home Care
Self Care

- Consumers increasingly independent
- Direct to Consumer Sales
- Directed Advertising
- Internet
- FDA Internet Site
- Increase from 30 million to 45 million hits per month in the last 6 months
- Some consumer brochures are downloaded a million times per year
- Home Care
- Self Care

**Information Empowered Consumers**

## Center for Devices and Radiological Health

*Question:*
*	**What will we lose if the scientific and regulatory **leadership and credibility of FDA is lost ?*
* **will the needs of Evidence Based medicine be met by “substantially equivalent to a pre-1976 device”?*
* **risk based inspection with decreasing assurance of conformance to quality standards?*
* **expansion the EU CE-mark clout as the de facto quality standard?*
*world-wide impact by regional concerns and experiences?*
* **will “precaution” replace “risk-benefit”*

## Center for Devices and Radiological Health

*Vision:*
*	**	**Ensuring the health of the public **	**throughout the *
*	**	**Total Product Life Cycle*

*	**	**	**	**	**— **it’s everybody’s business*