# Presentation: 544279

## CDRH UpdateFacilitating Medical Device Innovation and Technology 

**CDRH Update****Facilitating Medical Device Innovation and Technology **

**Dan Schultz, MD**
**Director, Center for Devices and Radiological Health**
**Food and Drug Administration**
**Sixth Annual National Forum on Biomedical Imaging in Oncology**
**Bethesda, MD**
**April 7, 2005**

## What is a Device?

**What is a Device?**

## A Computer That Helps You Hear

## Miniaturized DevicesElectrical Stimulators

**Pacemakers**

**Notes:**
In addition to the advances in pacemakers and implanted cardiac defibrillators, there are other areas that electrical simulators are being used and studied.  

Treatment for Obesity

Several companies both in and outside the US are currently studying electrical stimulation of the stomach wall to treat obesity. Electrical leads are placed into the muscle of the stomach wall and intermittent electrical stimulation is provided by an implanted stimulator. Although the exact mechanism is not known, it is believed that the effects may be from indirect stimulation of the vagus nerve (which interacts with the satiety center in the brain) leading to less eating and weight loss.

Treatment for Depression

Another example is the vagal nerve stimulation system for adjunctive long-term treatment of chronic or recurrent depression for patients who are experiencing a major depressive episode that has not had adequate response to two or more antidepressant treatments.   

##  “Smart” Drug Delivery Devices

**Information-Rich Therapeutics**

** “****Smart” Drug Delivery Devices**

**Notes:**
Some companies are working on a closed loop insulin system for diabetics in which an implantable system both monitors systemic glucose levels and adjusts the amount of insulin delivered based on the readings.

To give you an idea of some of the scientific challenges we face – we need are making sure that the glucose sensor reads correctly, that the device administers the right dose of insulin, that the device can be appropriately used and programmed by healthcare providers and patients and that there is not interference with other electronic radiation emitting devices such as metal detectors or hospital monitors.

## Combination ProductsDrug-Eluting Stents 

_**Components**_
**Stent Platform & Delivery System**
**Carrier(s)**
**Drug**

## Intelligent DevicesStent as a Radiofrequency Identifier

**Preclinical Model of Self Monitoring Stent**
**Applications: detect restenosis**
**Measure blood pressure continuously**

**Yogesh Gianchandani and his team at the University of Michigan **

## Minimally Invasive DevicesImage (MRI) Guided Treatment (HiFU)

**Diagnostics and Therapeutic Device**
- Uses magnetic resonance image (MRI) guided focused ultrasound to **target** and **destroy** non-cancerous uterine fibroids

**Minimally Invasive Devices****Image (MRI) Guided Treatment (HiFU)**

## Medical Imaging Devices 

**Digital Mammography**
**Produces images using X-rays instead of film **

**Image Analysis Software**** Aids in the detection of lung nodules**

## Technology for Special Populations 

**Left  Ventricular Assist Device for Pediatric Use**

**Stair-Climbing Wheelchair**

## Technology Designed for Home Use

**Home Testing for HIV**

**A Defibrillator for the Home**

## Point of Care Diagnosis and Therapy Devices

**Enhancement of point of care testing****  **
**Enhanced portability of increasingly complex laboratory analysis**
**Example: A portable test has been approved by CBER for HIV**
**CDRH expects other high risk technologies to follow**

**Notes:**
Enhancement of point of care testing.  Improvement and refinement in chemical and immunochemical methods have allowed for enhanced portability of increasingly complex analysis.  Most recently a portable test has been approved by CBER for HIV and CDRH expects other high risk technologies to follow.

## Biological Medical DevicesGenomics

**Impact on Therapeutic Products**
**New knowledge about disease**
**Animal models**
**Pharmacogenomics:**
**Identify responders**
**Understand toxicity**
**Clinical diagnosis**
**Clinical treatment monitoring**

**Personalized Medicine**

## Biological Medical DevicesBiotechnology Revolution

**Microarray Technology**** **
**Providing insight into patient factors allowing for personalized medicine**
**Amplichip**

**Personalized Medicine**

**Notes:**
With microarray technology DNA chips can be used to measure the genetic variations of patients.  These chips are capable of making multiple measurements from a single sample and providing information that provides insight into patient factors that allow for personalized or individualized medical choices. FDA has recently approved the first product in this line, the Roche amplichip for P45O activity measurement.  

Some of the scientific and regulatory challenges in approving these devices are:

## Technology We Hope We Never Need Bioterrorism Diagnostic Testing 

**Bioterrorism Diagnostic Testing**
**Testing for biological warfare agents including microbes and toxic chemicals**
**Biosensor detectors **
**Nucleic acid amplification **

**Challenge: ****Studies using real clinical samples may not be possible so flexible regulatory and scientific alternatives are essential**

**QuickELISA Anthrax-Pa Kit**
- The first rapid serum antibody test for anthrax

## What are the challenges today
for bringing new medical 
technology to market?

Accelerated Pace of Technology and Innovation
Complexity of New Technology

**for bringing new medical **
**technology to market?**
**Accelerated Pace of Technology and Innovation**
**Complexity of New Technology**

**Technology and Innovation**

## The Accelerating Pace of Technology and Innovation Advances in Medical Imaging

**The Accelerating Pace of Technology and Innovation**** ****Advances in Medical Imaging**

## The Accelerating Pace of Technology and Innovation Advances in Medical Imaging

**The Accelerating Pace of Technology and Innovation**** ****Advances in Medical Imaging**

**41 CT slices**

## The Accelerating Pace of Technology and Innovation Advances in Medical Imaging

**The Accelerating Pace of Technology and Innovation**** ****Advances in Medical Imaging**

**3-D CT Imaging**

## The Accelerating Pace of Technology and Innovation Advances in Medical Imaging

## Medical Device Industry Growth

**Dun & Bradstreet Medical Device Firm Data**

**Number of Manufacturers by Year**

## Sales Volume Growth

**Note: No economic adjustment to dollar value**

**(Billions of Dollars)**

## The Complexity of New Technologies

**Devices are getting smaller **
**Miniaturization, New Materials, Nanotechnology**
**Devices are getting smarter and are providing more information**
**Intelligent Devices**
**Biotechnology Revolution**
**Personalized Medicine **
**Combination Products**
**Information-Rich Therapeutics**

##  The Complexity of New Technologies

**Devices are becoming more convenient for the patient**
**Home Use **
**Minimally Invasive**
**Point of Care Diagnostics **
**Devices are responding to heighten homeland security**
**Bioterrorism-Related Devices**
**Devices are meeting the needs for special populations**

## Technology and InnovationFDA Role

**Technology and Innovation****FDA Role**

**Establish **_***reasonable***_**      **
**assurance of the safety and **
**effectiveness of medical devices **
**marketed in the U.S.**

**Notes:**
I’d like to thank you again for all that you are doing to support biomedical innovation and to let you know that we’re looking forward to working with you in the months ahead to further capitalize on our scientific innovations and help bridge the gap between bench and bedside 

## Technology and InnovationCDRH Challenges

**Effectively Managing a Changing Workload**
**Increasing number of expedited submissions, combinations products and submissions with clinical data**
**New Kinds of Scientific Expertise**
**Meeting MDUFMA Commitments**
**Performance goals**
**Third-party inspections**
**Establishing a Premarket/Postmarket Balance**
**Greater degree of scrutiny**

## Medical Device Program

**Medical Device Program**

| TYPE OF SUBMISSION | FY 99 | FY 00 | FY 01 | FY 02 | FY 03 | FY 04 |
| --- | --- | --- | --- | --- | --- | --- |
| Original PMA* | 64 | 67 | 71 | 49 | 54 | 51 |
| PMA Supplement* | 557 | 546 | 641 | 645 | 666 | 635 |
| Original IDE | 304 | 311 | 284 | 312 | 242 | 226 |
| IDE Amendment | 275 | 240 | 206 | 252 | 216 | 167 |
| IDE Supplement | 4,127 | 4,388 | 4,811 | 4,724 | 4,415 | 4,312 |
| 510(k) – 10% with clinical data* | 4,458 | 4,202 | 4,248 | 4,320 | 4,247 | 3,635 |
| Original HDE | 12 | 11 | 5 | 5 | 10 | 9 |
| HDE Supplements | 4 | 10 | 16 | 16 | 29 | 29 |
| Total | 9,801 | 9,775 | 10,282 | 10,323 | 9,879 | 9,064 |

*******	****The majority of PMAs and 510(k) applications are subject to fees.  Exceptions include small business and pediatric applications.**

**CDRH: Types and Numbers of Submissions Received**

## These are the issues that we face everyday...

**Implementation of the ****Medical Device User Fee and Modernization Act of 2002****...**** **

**... ****a complex and comprehensive **
**set of review goals, **
**becoming more aggressive **
**each year****.**** **

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

** **

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

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

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

## The complexity and need for clinical data is growing...

**Embolic protection devices**

**Vascular anastomosis devices for CABG**

**Image-guided bronchoscopes**

**Barbed sutures**

**Glaucoma shunts**

***Daily wear contact lenses***

***CPAP devices for apnea***

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

## BioterrorismEmergency Measures

**Bioterrorism****Emergency Measures**

**Emergency Preparedness**** - Medical device emergency shortages database**
**Bioterrorism Diagnostics and Testing**** - QuickELISA Anthrax-Pa Kit, the first rapid serum antibody test for anthrax**
**ASTM F2401-04**** -  “Standard Practice for Security Checkpoint Metal Detector Screening of Persons with Medical Devices”**

## Meeting Technology Innovation Challenges

## Meeting the Challenges of Technology and Innovation

**Strategic planning helps us achieve our goals and establish a vision for the future**
**Meeting MDUFMA Goals**
**Strengthening our workforce for  the 21st century****	**
**Enhancing our knowledge management**
**Achieving a better pre/postmarket regulatory balance**

## CDRH FY 05

| 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.
Vision:  Ensuring the health of the public through out the Total Product Life Cycle (TPLC) |  |  |  |  |
| --- | --- | --- | --- | --- |
| Public Health Impact
Measure, assess, improve and communicate our impact on public health | Magnet for Excellence
Attract and retain a diverse work force to accomplish our public health mission | CDRH
Strategic 
Goals | Knowledge Management
Enhance use of information and communication systems to support TPLC | TPLC
Align CDRH programs to effectively manage the product life cycle |
| Meet MDUFMA performance goals | Strengthen our workforce for  the 21st century | CDRH 
Priorities | Enhance our knowledge management | Achieve better pre/postmarket regulatory balance |
| Public Health Promotion
Assess and improve time to market for medical devices
Public Health Protection
 Assess and improve risk management, identifying and resolving public health hazards | Workforce Excellence
Attract, develop and retain a highly skilled and diverse workforce to advance our public health mission  | Scorecard
Key Result
Areas | Knowledge Management  
Communicating with our stakeholders to meet public health challenges throughout the TPLC  | TPLC
Effective Management in Accordance with TPLC Principles  |
| FY 05 MDUFMA  performance goals
Quality system for application review
Review consults
CoA studies
Risk -based inspections
MedSun and LabSun
Medical device reports (MDR)
Emergency Measures | Priority hiring 
Professional development
External expertise (MDFP and other initiatives)  | Priority
Initiatives | Guidance/standards
Targeted IT initiatives
Infrastructure upgrades
Turbo 510(k)
eConsult
Communicating medical technology | OIVD Model
Research prioritization
Radiological Health Strategy
GHTF
Organizational scorecards
Project management plans 
Move to White Oak  |
| Technology Development and Innovation
Patient and Consumer Protection
Protecting the Homeland -- Counter Terrorism
Risk-Based Management Practices | Improving FDA's Business Practices | Relationship to
FDA Goals | Patient and Consumer Protection
Empowering Consumers in Public Health | Improving FDA's Business Practices |

## Priority Hiring

| Office | Hired
 FY 03  | Hired  
 FY 04 | Two Year Totals Total MDUFMA Hires 
(#Shared) |
| --- | --- | --- | --- |
| Total | 75 | 57 | 132    (18 Shared) |
| OC | 10 | 7 |   17    (1 Shared) |
| ODE | 29 | 15 |   44    (6 Shared) |
| OCR | 4 | 2 |     6    (0 Shared) |
| OIVD | 11 | 6 |   17    (0 Shared) |
| OSB | 6 | 11 |   18    (1 Shared) |
| OSM/OCD | 4 | 3 |     6    (0 Shared) |
| OSEL | 11 | 13 |   24    (11 Shared) |

**FY 03 and FY 04 Hires (by Specialty)**

## Develop training programs
Provide professional and career development opportunities
Science Leadership Education Program (SLEP)
Basic Science Education Program (BSEP)
Develop competency models
Science
Management
Business

**Provide professional and career development opportunities**
**Science Leadership Education Program (SLEP)**
**Basic Science Education Program (BSEP)**
**Develop competency models**
**Science**
**Management**
**Business**

**Professional Development**

## Premarket reviews and consults
 Human factors issues
 Analysis of device failure modes
 Standards and guidance development
 Statistical analyses

** ****over 100 fellows in the program**
**www.fda.gov/cdrh/mdfp **

**Premarket reviews and consults**
** ****Human factors issues**
** ****Analysis of device failure modes**
** ****Standards and guidance development**
** ****Statistical analyses**

**External Expertise**

**Medical Device Fellowship Program (MDFP)**

## Guidance Development

**Create a list of high priority guidances**
**Establish performance goals **
**Develop tracking mechanisms **
**Engage industry stakeholders in the early stages of guidance development**

## Standards Development

**Recognition – to have significant influence throughout the world**
**Participation – to work with national and international committees**
**	****CDRH Standards Participation**
**38 development organizations**
**238 Liaison Reps****: ****220 National Committees and 128 International Committees**
**538 Standards Activities****: ****365 National and 173 Other Activities**
**Utilization **
**Standards utilization in recent device applications - 55% **

## Global Harmonization Task Force

**Develop  guidance documents on basic regulatory practices**
**Continue participating in GHTF study groups**
**Study Group 1: regulatory and premarket requirements **
**Study Group 2: postmarket vigilance**
**Study Group 3: quality systems**
**Study Group 4: regulatory auditing of quality systems **
**NEW Study Group 5: Clinical Evidence**

**Mission: Encourage the convergence of medical device regulatory practices worldwide where possible, while ensuring the safety, effectiveness, and quality of medical devices.**

## Quality Systems for Application Review

**Focus on selected cross-cutting areas**
**e.g., biocompatibility**
**Use retrospective (post-decision) peer assessments **
**Assemble quality assessment teams**
**Continue with pilot program**

## IT Initiatives 

**Premarket Review Modernization**
**Postmarket Medical Device Reporting *****(eMDR)***
**ODE and OC Tracking Systems**

**Electronic Registration and Listing**
**eConsult **
**Image2000**
**Turbo 510(k)**

## IT Initiatives Image2000 

**Scan outgoing 513g and reduce backlog**
**Decrease original PMA scanning times **
**Scanning 510(k) in real time**
***Electronic copies to eliminate need for scanning***

## IT Initiatives Turbo 510(k)

**Continue pilot *****eSubmission***** with industry volunteers**
**Develop *****eLoader***** tool for reviewers, allowing copy and paste from *****eSubmission***** into external applications**
**Develop eReview tool, a standard 510(k) review template**

## Research Prioritization

**Research Prioritization**

**Criteria For Rating Projects**
**R****egulatory need: PMA and IDE activity**
**Scientific gaps and technical competence: leading edge products**
**Public health impact: mortality, morbidity, quality of life**

**FY 05 Goals**
**Continue using prioritization model**
**FY 04 Update **
**73 projects (14 programs)**
**Approximately 90 TRC members participated**
**Approximately 145 OSEL staff are involved**
**72 TRC members from CDRH, and the rest from CDER, CBER, EPA, NIST, etc.**

## Critical Path Research  

**Leverages basic science knowledge**
**Leverages cumulative research experiences**

***Does not compromise safety and effectiveness evaluations***

## Critical Path Research

**Update**
**We have reviewed and compiled all of the comments received on the public docket**
**Critical Path Public Docket**
**	*****Solicited thoughts on areas benefit from research and  development of critical path evaluative tools***
**We are nearing completion the National Critical Paths Opportunities List**

## Organizational Scorecards

**FY 05 Goals**
**Update Center scorecards, includes implementing Quality review Assessment metrics**
**Develop a pilot automated scorecard tool **

**Scorecards help manage organizational performance in CDRH strategic areas**

## Project Management Plans

**FY 05 Goals**
**	****Effectively manage long term projects and new initiatives**
**Project milestones**
**Resource requirements**
**Quarterly reports**
** **

## Improving InfrastructureWhite Oak

**Life Sciences building opened Dec. 2003**
**Shared between CDRH and CDER**
**Considerable progress on the CDER Office building and the Award-winning Shared Use building**

**Engineering and Physics building**
**100% design**
**Expected occupancy Spring 2006**

## Working Towards Meeting  Performance Goals

- MDUFMA

## Original PMA Milestones

**Scientific Review**

**Interactive Rev**

**Original PMA Milestones**

**Filing Review**

**Panel Planning**

**Closeout Review**

**PMA Received**

**Panel Go/No Go**

**Panel Meeting**

**Filing Letter**

**Final Decision**

**320 days**

**Major **
**Deficiency **
**Letter**

**Clock **
**Stops**

**Status Letter**

**Consults Complete**

**2-cycle scenario**

## Original PMA Milestones

**Original PMA Milestones**

**Filing Review**

**Scientific Review**

**Panel Planning**

**Closeout Review**

**PMA Received**

**Final Decision**

**180 days**

**Status Letter**

**Consults**
**Complete**

**Interactive Review**

**1-cycle scenario**

**Panel Go/No Go**

**Filing Letter**

**Panel Meeting**

## MDUFMA Performance Goals 

| Performance Measured at | FY 2003 Cohort
Goal:  None until FY 2006 | FY 2004 Cohort
Goal:  None until FY 2006 | FY 2005 Cohort
Goal:  None until FY 2006 |
| --- | --- | --- | --- |
| 3 months into FY | 88.9% | 100.0% | — |
| 6 months into FY | 93.3% | 100.0% |  |
| 9 months into FY | 96.6% | 100.0% |  |
| End of FY (12 months) | 97.4% | 100.0% |  |
| 15 months after start of FY | 97.4% | 100.0% |  |
| 18 months after start of FY | 97.6% |  |  |
| 21 months after start of FY | 97.6% |  |  |
| 24 months after start of FY | 95.1% |  |  |
| 27 months after start of FY | 95.2% |  |  |
| Remaining to close cohort | 5 (of 47) | 25 (of 47) | TBD |

**PMAs and Panel-track Supplements**
**FDA Decisions within 320 Days**

**Notes:**
Percentages shown are percent of decisions made within 320 days.
“Remaining to close cohort” reflects status on 31 December 2004.

## MDUFMA Performance Goals

| Performance Measured at | FY 2003 Cohort
Goal:  None until FY 2005 | FY 2004 Cohort
Goal:  None until FY 2005 | FY 2005 Cohort
Goal:  75% |
| --- | --- | --- | --- |
| 3 months into FY | 100.0% | — | — |
| 6 months into FY | 100.0% | 100.0% |  |
| 9 months into FY | 100.0% | 84.6% |  |
| End of FY (12 months) | 100.0% | 85.0% |  |
| 15 months after start of FY | 86.4% | 84.0% |  |
| 18 months after start of FY | 84.0%  |  |  |
| 21 months after start of FY | 84.0%  |  |  |
| 24 months after start of FY | 84.0%  |  |  |
| 27 months after start of FY | 84.0%  |  |  |
| Remaining to close cohort | — | ≤ 5 | TBD |

**PMAs and Panel-track Supplements****First Action = “Major Deficiency” Letter within 150 Days**

**MDUFMA Performance Goals**

**Notes:**
Percentages shown are percent of actions made within 150 days.  A checkmark indicates the cohort is closed.
Because we cannot know whether the first action will be a “major deficiency” letter, the number shown for “Remaining to close cohort” is the number of applications that do not have a first action.

## MDUFMA Performance Goals

| Performance Measured at0 | FY 2003 Cohort
Goal:  None until FY 2005 | FY 2004 Cohort
Goal:  None until FY 2005 | FY 2005 Cohort
Goal:  80% |
| --- | --- | --- | --- |
| 3 months into FY | 87.7% | 86.4% | 100.0% |
| 6 months into FY | 86.3% | 89.2% |  |
| 9 months into FY | 89.9% | 92.9% |  |
| End of FY (12 months) | 91.9% | 97.3% |  |
| 15 months after start of FY | 93.6% | 97.6% |  |
| 18 months after start of FY | 94.1% |  |  |
| 21 months after start of FY | 94.6% |  |  |
| 24 months after start of FY | 94.1%  |  |  |
| 27 months after start of FY | 94.1%  |  |  |
| Remaining to close cohort | — (of 203) | 18 (of 103) | TBD |

**180-day Supplements****FDA Decisions within 180 Days**

**Notes:**
Percentages shown are percent of decisions made within 180 days.

## MDUFMA Performance Goals

| Performance Measured at | FY 2003 Cohort
Goal:  None until FY 2005 | FY 2004 Cohort
Goal:  None until FY 2005 | FY 2005 Cohort
Goal:  80% |
| --- | --- | --- | --- |
| 3 months into FY | — | — | 100.0% |
| 6 months into FY | 0.0% | 83.3% |  |
| 9 months into FY | 9.1% | 80.0% |  |
| End of FY (12 months) | 14.3% | 87.5% |  |
| 15 months after start of FY | 16.7% | 89.2% |  |
| 18 months after start of FY | 16.1% |  |  |
| 21 months after start of FY | 16.1% |  |  |
| 24 months after start of FY | 16.1%  |  |  |
| 27 months after start of FY | 16.1%  |  |  |
| Remaining to close cohort | — | ≤ 16 | TBD |

**180-day Supplements****First Action = “Not Approvable” Letter within 120 Days**

**MDUFMA Performance Goals**

**Notes:**
Percentages shown are percent of actions made within 120 days.

## MDUFMA Performance Goals

| Performance Measured at | FY 2003 Cohort
Goal:  None until FY 2005 | FY 2004 Cohort
Goal:  None until FY 2005 | FY 2005 Cohort
Goal:  75% |
| --- | --- | --- | --- |
| 3 months into FY | 100.0% | 100.0% | 100.0% |
| 6 months into FY | 96.1% | 95.6% |  |
| 9 months into FY | 90.7% | 90.7% |  |
| End of FY (12 months) | 87.1% | 89.0% |  |
| 15 months after start of FY | 83.7% | 87.3% |  |
| 18 months after start of FY | 79.4% |  |  |
| 21 months after start of FY | 77.3% |  |  |
| 24 months after start of FY | 76.4% |  |  |
| 27 months after start of FY | 76.0% |  |  |
| Remaining to close cohort | 25 (of 3,752) | 376 (of 3,411) | TBD |

**510(k)s****SE, NSE Decisions within 90 Days**

**Notes:**
Percentages shown are percent of decisions made within 90 days.
Cohort changes over time – it is reduced when we find that a submission was exempt from 510(k) or is not a device.

## MDUFMA Performance Goals

| Performance Measured at | FY 2003 Cohort
Goal:  None until FY 2005 | FY 2004 Cohort
Goal:  None until FY 2005 | FY 2005 Cohort
Goal:  70% |
| --- | --- | --- | --- |
| 3 months into FY | 90.0% | 93.5% | 99.6% |
| 6 months into FY | 66.2% | 74.4% |  |
| 9 months into FY | 60.2% | 76.0% |  |
| End of FY (12 months) | 59.1% | 78.5% |  |
| 15 months after start of FY | 57.9% | 78.4% |  |
| 18 months after start of FY | 57.8% |  |  |
| 21 months after start of FY | 57.9% |  |  |
| 24 months after start of FY | 57.9% |  |  |
| 27 months after start of FY | 57.9% |  |  |
| Remaining to close cohort | ≤ 25 | ≤ 376 | TBD |

**510(k)s****First Action = “Additional Information” Letter within 75 Days**

**MDUFMA Performance Goals**

**Notes:**
Percentages shown are percent of actions made within 75 days.

## Assuring Postmarket Medical Device Safety 

**Assuring ****Postmarket ****Medical Device Safety**** **

**FDA **
**under scrutiny**

**Identifying adverse events so rare or that occur under specific conditions**

## New Claims Add To Data That Put Vioxx Drug On Hot Seat 

** ****New Vioxx, Celebrex Studies Show Mixed Results**

**FDA panel votes to allow Vioxx back on market**

**FDA Issues Public Health Advisory on Vioxx as its Manufacturer Voluntarily Withdraws the Product **

**A Reminder That No Drug Is Risk-Free **
**F.D.A. Panel Says Pain Relievers Should Remain on Market **

**FDA opens hearing on safety of arthritis drugs **

## Drug-coated stents may face additional FDA scrutiny

**Drug-coated stents may face additional FDA scrutiny**

**FDA Advises Physicians of Adverse Events Associated with Cordis Cypher Coronary Stents**

## Device GMP/QS Inspection Trends

**Device GMP/QS Inspection Trends**

**Statutory Requirement**

## Risk-based Inspections

- Links Between Process (GMP) Risks and Patient Risks are Lost

**Risk-based Inspections**

**RISK ******** **

**Processes**
** ****Inspection Risk **

**cGMP**

**RISK ******** **

**Quality Patient) Factors **

**Patient**

**Correlation?**

**RISK ******** **

**Processes Inspection Risk **

**RISK ******** **

**Quality (Patient) Factors**

**GMP**

**Patient**

**Goal**Prioritize Actions on GMP Risks Correlating to Patient Risks

## Third Party Inspection Program

**Inspections of eligible manufacturers of Class II and Class III medical devices by accredited persons**
**Inspections by accredited persons conducted in essentially the same manner as those conducted by FDA**
**Inspections by accredited persons conducted independent of third party inspections performed under the U.S./EC Mutual Recognition Agreement (MRA)**

## Third Party Inspection Program

**Update**
**Implemented MDUFMA authority to accredit third parties**
**Issued guidance **
**Published criteria for accredited persons **
**Selected 15 third parties to participate in the program **

## Achieving Pre/Postmarket Balance

**Achieving Pre/Postmarket Balance**

## A start, not a cure, for FDA 

**A start, not a cure, for FDA **

**FDA to create drug safety board**
**Independent panel to monitor medicines once they're on market**

**F.D.A. Moves Toward More Openness With the Public**

**FDA to Institute Safety Board****The goal is to more quickly identify problems with drugs and to issue alerts. The agency has been under growing pressure to act. **

## Building Better Reporting SystemsAdverse Event Reporting System

**Voluntary reporting since 1973 (3%)**
**Mandatory reporting **
**Since 1984 - manufacturers (93%)  and Importers (1%) **
**Since 1990 - user facilities (3%)**
**125,000 reports/year; 1.25 million total**

**Mandatory**
**Reporting**

**FDA**

**Voluntary**
**Reporting**

**Product Problems**

**Clinical Problems**

**Notes:**
Our device adverse event and product problem reporting system is comprised of both mandatory and voluntary components.  The system is a nation-wide passive reporting system, meaning that it is reporter-initiated and, although we encourage reports, we do little to actively solicit them.  The voluntary component dates back to 1973 and is currently know as MedWatch.  It accounts for about 3% of total reports.  Although reports can be submitted by anyone, health professional reports are the most useful due to the background of the reporter.  

Mandatory reporting dates back to 1984 and was instituted under the Medical Device Reporting regulations.  Currently, manufacturers and importers are required to report device-related death, serious injury, and malfunctions.  They account for about 93% and 1% of total reports, respectively.  Since 1990, under the Safe Medical Devices Act, user facilities have been required to report deaths and serious injuries to the manufacturer and deaths to the FDA.  User facilities are defined as hospitals, nursing homes, ambulatory surgical facilities, outpatient diagnostic and treatment facilities, and ambulance services.  Although they represent over 60,000 establishments in the U.S., user facilities only account for about 3% of total reports.

Last year, FDA received approximately 125,000 reports and has received about 1 1⁄4 million reports since 1973.  About 3,000 of the reports received last year note ages in the pediatric range.   

## Building Better Reporting Systems Medical Device Reporting (MDR)

**Building Better Reporting Systems**** Medical Device Reporting (MDR)**

**Expedite analysis of reported serious injuries**
**Implement Phase 1 of *****eMDR***** **
**Timely access, review and action on available and new reports**
**FY 04 Update**** **
**57,600 reports from manufacturers, user facilities, and importers **
** ****3887 voluntary reports from health care professionals and the public**** **

## Building Better Reporting Systems MedSun and LabSun

**The  Medical Product Surveillance Network (MedSun) is an interactive, internet-based reporting program.**

**Continue recruitment of reporting facilities**
**FY 04 Update: 299 facilities nationwide**
**FY 05 Target: 350 facilities nationwide**
**Target reports from laboratories (pathology and in vitro diagnostic tests) in the reporting hospitals (LabSun)**
**Increase reporting from hospital laboratories**

## Condition of Approval (CoA) Studies

**Transfer tracking and follow-up to postmarket **
**Develop tracking system**
**Involve epidemiology staff in PMA review**
**Develop postmarket plan (identify products risk)**
**Postmarket studies designed to address postmarket questions**
**Prompt follow-up with sponsors when requirements not being met **

## Condition of Approval (CoA) Studies

**Feedback and interaction with sponsor as CoA study progresses**
**Public availability of study status on Agency website**
**Panel feedback with updates, industry or CDRH**
**Mandate postmarket study if needed**

## Communicating Medical Technology 

**As new technology emerges, it is not only our responsibility to assure its safety and effectiveness, but also to communicate its existence and usefulness to the public at large.**

## Educating Healthcare Providers and Protecting Consumers through Information

**Safety Alerts**
**Public Health Notifications**
**Labeling Changes**
**Scientific Publications**

**FDA Patient Safety News**
**Patient Safety Portal**
**Recalls and Other Regulatory Actions**

## Protecting Consumers through Information

**CDRH Disease and Product- specific Websites**
**Diabetes Information **_**www.fda.gov/diabetes**_
**HeartHealth Online **_**www.fda.goc/hearthealth**_
**LASIK www.fda.gov/cdrh/lasik**
**Whole-Body Scanning Using CT **_**www.fda.gov/cdrh/ct**_
**Cochlear Implants **_**www.fda.gov/cdrh/cochlear**_

## Educating Healthcare Providers and Consumers

**Communicating the existence and usefulness of new technologies**
**One Pagers – New Device Approvals            **_**www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/mda/mda-list.cfm?list+1**_
**Utilizing the internet in various ways to promote communication and education**
**ListServes – Breast Implants **_**www.fda.gov/cdrh/bicl**_

## Providing Industry Assistance

**Division of Small Manufacturers, International, and Consumer Assistance **
**Phone:  800-638-2041 or 301-443-6597**
**Email:   **_**DSMICA@cdrh.fda.gov**_
**Website www.fda.gov/cdrh**
**Educational Programs**
**Guidance**
**Teleconferences**
**Labeling**
**Human Factors**

## Facilitating Technology and Innovation

| Technology and Innovation Challenges | Role of FDA | Meeting the Challenge |
| --- | --- | --- |
| Accelerated Pace of Technology and Innovation

Complexity of New Technology | Establishing safety and effectiveness  of complex technologies faster and cost-effectively

Assuring postmarket medical device safety by identifying adverse events so rare or that occur under specific conditions

Communicating medical device existence and usefulness to the public | CDRH Strategic Planning
Meeting MDUFMA Goals
Strengthening our workforce for  the 21st century	
Enhancing knowledge management
Achieving pre/postmarket  balance
Conducting business in an open and transparent manner |

## Slide 80

**Notes:**
And they interconnect.  They interconnect because all parts of the cycle inform and are pathways to other parts.  They interconnect because products further along in the cycle inform and affect new products earlier in the cycle.  They interconnect because a safe and effective device or radiological health product can’t be developed without some knowledge of all the parts.