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Office of Device Evaluation Annual Report Fiscal Years 2006 and 2007
(Preface and Table of Contents)

U.S. Department of Health and Human Services Public Health Service Food and Drug Administration Center for Devices and Radiological Health

Acknowledgements

Thanks to the following organizations for their invaluable assistance in preparing this report:

ODE Program Operations Staff
ODE Review Divisions
ODE Program Management Office
OMO Division of Planning, Analysis and Finance
OMO Division of Information Technology Management

Robert R. Gatling, Project Director
Cathy Hobbs, Editor
MaryAnn Gornick, Production Specialist

Table of Contents

Preface

Part 1 – Advances in Patient Care

• FY 06 Section
  • Heart Devices
  • Septal Occluders
  • Bone Void Fillers, Dental
  • Adhesion Prevention
  • Hip Prostheses
  • Cervical Cancer
  • Spinal Implants
  • Loss of Smell
  • Infection Control
• FY 07 Section
  • Urethral Stents
  • Excimer Laser
  • Bone Graft
  • Infants
  • Washer/Disinfector, Infection Control
  • Respirator for General Use
  • Remote Medication Management System
  • Cervical Disc System
  • Absorbable Suture
  • Aneurysms
  • Breast Implants
  • Limb Salvage Shunt
  • Application Activity
  • FY 06 Original PMA/HDE Approvals
  • FY 07 Original PMA/HDE Approvals
  • FY 06 Expedited Original and Panel Track Supplement PMA Approvals
  • FY 07 Expedited Original and Panel Track Supplement PMA Approvals
  • De Novos Cleared in FY 06
  • De Novos Cleared in FY 07
  • FDA Consumer Websites
  • Publicly Available Device Databases
  • Consumer Information

Part 2 – Reports from ODE Divisions

• Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (DAGID)
  • DAGID Staff Subject Matter Experts on Emergency Preparedness and Influenza
  • DAGID launches the “Reviewer Round Table” Series
  • Interagency Working Group
  • Infusion Working Group
  • CDRH Artificial Pancreas Working Group
  • Dental Branch Represents FDA as Liaison to the American Dental Association Council on Scientific Affairs
• Division of Cardiovascular Devices (DCD)
  • Coronary Drug-Eluting Stent Safety Evaluation Initiative
  • FDA/NSF/NIH Computer Methods in Cardiovascular Device Design & Evaluation Workshop
  • Lead Surveillance Process Workshop
• Division of General, Restorative and Neurological Devices (DGRND)
  • Leveraging with Outside Groups
  • Expanding Our Scientific Knowledge Base
  • Reclassification Efforts
  • Public Health Protection/Total Product Life Cycle Efforts
• Division of Ophthalmic and Ear, Nose and Throat Devices (DOED)
  • Outreach to the Public and the Clinical Community
  • Building Scientific Knowledge Through Collaborative Research
• Division of Reproductive, Abdominal, and Radiological Devices (DRARD)
  • Condom Labeling Review Initiative
  • Biliary Stents
  • Standards Development for Urology and Lithotripsy Devices

Part 3 – Magnet for Excellence

• Leadership Readiness Program
• ODE Staff Receive Outside Honors
• DAGID Awards and Special Recognition
• DGRND Awards and Special Recognition
• DOED Awards and Special Recognition
• DRARD Awards and Special Recognition
• Standards
• International Outreach

Part 4 – Major Program Initiatives

• Pandemic and Avian Influenza
• Program for Assessing the Quality of Premarket Review Memos
  • Serility Assessments
  • Biocompatibility Assessments
  • Software Assessments
  • Clinical Assessments
• Transfer of Post-Approval Study Responsibilities
• ODE Collaborative Reviewer Program
• Leveraging IT Systems for Increased Efficiency
  • Electronic Copies
  • Information Systems for Document Tracking and Archiving
  • Improved Communication and Interaction Tools for PMA Review Teams
  • Hardware Upgrades
• The Defibrillation Working Group (DWG)
• Combination Products
• ODE Device Guidance Documents - FY 06
• ODE Device Guidance Documents - FY 07
• Reclassification Petitions
• Proposed Reclassification Actions – FY 06 and FY 07
• Final Reclassification Petition – FY 07
• Denial of a Reclassification Petition – FY 06 and FY 07
• Advisory Panel Activities
• ODE/OIVD Application Integrity Program

Part 5 – Key Performance Indices

• Major Submissions Received
• Table 1. Major Submissions Received
• ODE Review Performance
  • Premarket Approval Applications (PMAs)
  • Figure 1: Average Total FDA Review Time for All Original and PT Supplements
  • Figure 2: Average Total Elapsed Time for All Original and PT Supplements
  • Figure 3:Average Total FDA Review Time to Final Decision for All 180 Day PMA/S
  • Figure 4: Average Total Elapsed Time to Final Decision for All 180-Day PMA/S
  • Figure 5: Average Total FDA Review Time for Real Time PMA Supplement
  • Product Development Protocols (PDPs)
  • 510(k) Review Performance
  • Figure 6: ODE 510(k)s: Average FDA Time to Final Decision
  • Figure 7: Average Total Elapsed Time to Final Decision
  • Third Party Review of 510(k)s
  • Figure 8: 510(k)s Received by ODE with a Third Party Review
  • Humanitarian Device Exemption (HDE) Applications
  • Investigational Device Exemptions (IDE) Applications
  • Figure 9: Average FDA Review Time for Original IDEs
• Performance on MDUFMA Goals
• Major Submissions Completed (Decision Cohort)
  • Table 2. Major Submissions Completed FY 97 – FY 07
  • Premarket Approval Applications (PMAs)
  • Premarket Notifications (510(k)s)
  • Investigational Device Exemptions (IDEs)
• Automatic Evaluation of Class III Designation
• 515(b)

Part 6 – Program Support

• Freedom of Information Requests
• Congressional Inquiries
• Publications
• ODE Vendor Day
• Mentoring Program
• Recruitment
• Other Than Hiring to Expand/Enhance Resources Program (OTHER)
• Device Evaluation Web Home Page
• Consumer Information

Appendix A – Summary of Major ODE Programs

• Premarket Approval Applications (PMAs)
• Product Development Protocols (PDPs)
• Humanitarian Device Exemptions (HDEs)
• PMA Supplements
• Investigational Device Exemptions (IDEs)
• IDE Amendments
• IDE Supplements
• Premarket Notifications (510(k))

Appendix B - ODE Publications

Appendix C - Selected FDA Websites

Appendix D - ODE Organization Chart

Appendix E - ODE Staff Roster

Preface

Dear Reader:

When we review our accomplishments, major challenges, and goals for 2006 and 2007, we are proud of what we have accomplished with our collective endeavors.

The passage of the Food and Drug Administration Revitalization Act of 2007 (FDARA) reauthorized FDA to collect user fees and contained other provisions for the medical device review program. FDARA also presents us with a more challenging set of performance goals. In order to meet these challenging new goals we have done several things. We developed an interactive review guidance document; modified our Center Tracking System (CTS) to enable staff to manage the new performance goals and the interactive review process; we are revising the original MDUFMA I PMA and 510(k) guidance documents to reflect the changes in the MDUFMA II legislation; we established new review timelines for original PMAs, PMA supplements, and 510(k)s to reflect the changes in the MDUFMA II legislation; and we have been developing essential training for all staff members on the new MDUFMA II performance goals, the interactive review process, and the new CTS features.

MDUFMA performance goals, Post-market Transformation, and rapidly advancing medical device technology present new challenges that necessitate further changes to the ODE program. I have the utmost confidence in our ODE staff for their continued support and commitment to promote and protect the public health. With all of us working together, we will be successful in meeting these challenges.

In closing, I want to acknowledge the support from our Center Director and the support from the other Offices in CDRH. Collaboration and communication are essential to the CDRH mission to promote and protect public health.

Donna-Bea Tillman,
Ph.D. Director
Office of Device Evaluation

Updated June 18, 2008

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