Medical Device Medical Device Regulatory Update Regulatory Update - PowerPoint PPT Presentation

Medical Device Medical Device Regulatory Update Regulatory Update Matthew Tarosky Tarosky Matthew Division of Bioresearch Monitoring Division of Bioresearch Monitoring Office of Compliance Office of Compliance Center for Devices and Radiological Health Center for Devices and Radiological Health US Food and Drug Administration US Food and Drug Administration 1

Presentation Topics Presentation Topics I ntroduction I ntroduction Priorities Priorities I nitiatives I nitiatives Guidance Documents Guidance Documents Non- -clinical (GLP) Program Update clinical (GLP) Program Update Non I nspection Metrics I nspection Metrics BI MO I nspection Preparation BI MO I nspection Preparation 2

CDRH’ ’s mission is s mission is… … CDRH Getting safe and Getting safe and effective devices effective devices to market as to market as quickly as … while ensuring while ensuring quickly as … possible… … that devices and possible that devices and radiological products radiological products currently on the currently on the market remain safe market remain safe and effective. and effective. Helping the public get science- - based accurate based accurate Helping the public get science information about medical devices and radiological information about medical devices and radiological products needed to improve health products needed to improve health 3

4 s vision is... vision is... Total Product Life Cycle Total Product Life Cycle ’s CDRH’ CDRH

Who We Are… … Who We Are CDRH is a team of over 1,000 dedicated, highly CDRH is a team of over 1,000 dedicated, highly skilled, and internationally respected public skilled, and internationally respected public health employees health employees Our employees are drawn from a wealth of Our employees are drawn from a wealth of science and public health professions science and public health professions Biologists, chemists, physicists, engineers, microbiologists, Biologists, chemists, physicists, engineers, microbiologists, statisticians, epidemiologists, physicians, nurses, statisticians, epidemiologists, physicians, nurses, pharmacologists, veterinarians, toxicologists, and specialists in n pharmacologists, veterinarians, toxicologists, and specialists i public health education and communication public health education and communication 5

CDRH’ ’s Organizational Chart s Organizational Chart CDRH Office of the Center Director Office of the Center Director Daniel G. Schultz, M.D., Director Daniel G. Schultz, M.D., Director Linda Kahan, Deputy Director Linda Kahan, Deputy Director Postmarket Transformation Postmarket Transformation Lillian Gill, D.P.A., Senior Associate Lillian Gill, D.P.A., Senior Associate Management Group Management Group Director Director CDRH CDRH Don S Don S t. Pierre t. Pierre Ombudsman Ombudsman Diane Mitchell, M.D. Diane Mitchell, M.D. Les Weinstein Les Weinstein S S usan Meadows usan Meadows Office of Office of Device Office of Office of Office of Office of Device Office of Office of Compliance Compliance Evaluation Evaluation Management Management Surveillance & Surveillance & Timothy A. Ulatowski Donna- -Bea Tillman, Ph.D. Bea Tillman, Ph.D. Timothy A. Ulatowski Donna Operations Operations Biometrics Biometrics Ruth E. McKee Ruth E. McKee S S usan N. Gardner, Ph.D. usan N. Gardner, Ph.D. Office of Office of Office of In Vitro Office of In Vitro Office of Office of Communication, Communication, Diagnostic Device Diagnostic Device S S cience & cience & Education, & Education, & Evaluation Evaluation Engineering Engineering Radiation Radiation & Safety & Safety Laboratories Laboratories Programs Programs S S teven I. Gutman, M.D. teven I. Gutman, M.D. Larry Kessler, S c.D. Larry Kessler, S c.D. Lynne L. Rice Lynne L. Rice 6

CDRH’ ’s Compliance Office s Compliance Office CDRH Office of Compliance Office of Compliance Tim Ulatowski Tim Ulatowski, Director , Director Larry Spears, Deputy Director Regulatory Larry Spears, Deputy Director Regulatory Kimber Richter, M.D., Deputy Director Medical Richter, M.D., Deputy Director Medical Kimber Division of Enforcement A Division of Enforcement B Division of Enforcement A Division of Enforcement B Gladys Rodriguez, Director Betty Collins, Director Betty Collins, Director Gladys Rodriguez, Director Division of Bioresearch Division of Risk Management Division of Bioresearch Division of Risk Management Monitoring Operations Monitoring Operations Karen Moss, Director Michael Marcarelli Michael Marcarelli, Director , Director Karen Moss, Director 7

What does the domestic medical What does the domestic medical device industry look like? device industry look like? Employees Per Firm* 6% 1% 3%5% 3% 1% 1% 1% < 10 7% 10 .. 29 30 .. 59 Largest Largest 16% Smallest 60 .. 99 Smallest Firms Firms Firms Firms 100 .. 499 66% 500 or more 90% Total Manufacturers* Total 2004 Sales N = 14,937 $320 Billion * Dun & Bradstreet 2004 Medical Device Firm Data * Dun & Bradstreet 2004 Medical Device Firm Data 8

Presentation Topics Presentation Topics Introduction Introduction Priorities Priorities Initiatives Initiatives Guidance Documents Guidance Documents Non- -clinical (GLP) Program Update clinical (GLP) Program Update Non Inspection Metrics Inspection Metrics BIMO Inspection Preparation BIMO Inspection Preparation 9

Priorities Priorities Medical Device User Fee & Modernization Act Medical Device User Fee & Modernization Act Postmarket Transformation Transformation Postmarket I nformation Technology I nformation Technology Staff Development Staff Development Device Critical Path Device Critical Path White Oak Campus White Oak Campus 10

Medical Device User Fee and Medical Device User Fee and Modernization Act of 2002 Modernization Act of 2002 MDUFMA I MDUFMA I Sunsets 9/30/07 Sunsets 9/30/07 Annual public stakeholder meetings Annual public stakeholder meetings MDUFMA I I MDUFMA I I Negotiations with industry over last 18 months Negotiations with industry over last 18 months Stronger performance goals Stronger performance goals More predictable user fee structure More predictable user fee structure Registration, annual reports Registration, annual reports Sent to Congress for review/approval Sent to Congress for review/approval 11

Postmarket Transformation Postmarket Transformation Connecting the dots… … Connecting the dots Premarket Approval Process Information Problem Internal Data Dissemination Adverse Event Assessment Analysis Inspections Groups Reporting Postmarket Postmarket Postmarket Problem Tools Public Health Problem Assessment Response Identification Tools Post External Data Additional Information Approval Laboratory Analysis Studies Signals Education Research & Enforcement Analysis Public Health Partners Postmarket Public Postmarket Problem Postmarket Problem Health Response Identification Assessment 12

Postmarket Transformation Postmarket Transformation Priorities Priorities 1. Create a matrix organization to optimize medical device regulation on 1. Create a matrix organization to optimize medical device regulati across the Total Product Lifecycle across the Total Product Lifecycle 2. Develop metrics and methods for tracking postmarket issues 2. Develop metrics and methods for tracking postmarket issues 3. Pursue the development of unique identification (UDI ) 3. Pursue the development of unique identification (UDI ) 4. 4. Propose mandatory electronic MDR reporting Propose mandatory electronic MDR reporting 5. Revise and update the MAUDE system, and expand the premarket 5. Revise and update the MAUDE system, and expand the premarket data- -warehousing warehousing data 6. 6. I ncrease the quality and quantity of Center/ ORA/ OCC interactions I ncrease the quality and quantity of Center/ ORA/ OCC interactions 7. Develop and implement a risk- -communication strategy communication strategy 7. Develop and implement a risk 8. Design a pilot project to test the usefulness of quantitative decision cision- - 8. Design a pilot project to test the usefulness of quantitative de making methods making methods 9. Enhance utility of MedSun programs 9. Enhance utility of MedSun programs 13

Matrix Organization Matrix Organization Establish cross- -cutting product cutting product- -related related Establish cross groups over the current functionally- - groups over the current functionally based organization to: based organization to: Foster information sharing and more effective PH Foster information sharing and more effective PH promotion and protection promotion and protection Collaboration as a part of day- -to to- -day operations, day operations, Collaboration as a part of day not just in crisis situations not just in crisis situations 14