Center for Devices and Radiological Health MassMedic May 2006

1. Center for Devices and Radiological HealthMassMedic May 2006 Larry Kessler, Sc.D. Director, Office of Science and Engineering Laboratories, CDRH

2. The State of the World: CDRH • How are we doing premarket? • How are we doing on compliance efforts? • How are we doing on surveillance? • How are we doing on communication? • What are new scientific challenges and how do they connect to FDA Critical Path Initiative?

4. Major Submissions Received (FY 99 – FY 04)

5. MDUFMAImplementation Reducing Review Time

6. New and Innovative Devices SurgiChip The first surgical marker with RFID technology ExAblate 2000 System The first to combine magnetic resonance imaging and focused ultrasound to target and destroy uterine fibroids Invader UGT1A1 Molecular Assay The first DNA-based test for a drug metabolizing enzyme (Personalized drug treatment decisions and drug therapy)

7. Premarket Review Quality Assessment Pilot ProgramEnsuring Quality in Premarket Review • The goal is to assess quality of review of premarket submissions using retrospective (post-decision) peer assessments • Pilot focuses on 3 areas of review: • Biocompatibility • Sterilization/Packaging • Statistics

8. Medical device recalls are increasing Trendline * FY 2005 Data as of 9/13/05

9. Medical device reports are increasing In FY 05 CDRH received about 176,000 reports >1,125,000 total

10. We are working on critical postmarket issues • Strengthening Condition of Approval studies • Improving targeted surveillance systems: MedSun • Focusing on risk-based inspections • Implementing third party inspections • Better communicating risk/benefit information • Improving our automated information systems

11. Working together to improve postmarket safety… • FDA collaborated in a postmarket workshop with AdvaMed • FDA, the Heart Rhythm Society and industry reps are exploring opportunities to improve Product Performance reports, PMA Annual reports and standardize our Dear Doctor letter format • FDA’s Defibrillation Working group focus on postmarket • Additional areas of active collaboration include recalls and unique device identifiers

12. Improve Communication and Education WWW.FDA.GOV/CDRH

13. Our Communication Strategy We're improving our automated information systems... • Easy-to-use databases of regulated products • Routinely-asked questions and answers • Developing methods of collecting and disseminating (“pushing out”) CDRH news • Improving CDRH web pages: • Medical Device Recalls - a web-friendly, plain language overview of medical device recalls http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/recalls.cfm

14. New Technology The GI Tract Camera • Important Trends • Miniaturization • Intelligent Devices • Minimally invasive • Biotechnology Revolution • New Materials • Combination Products • Disruptive Technologies • That change how we do business • That change how medical devices deliver value

15. Market Application Approval Basic Research Prototype Design or Discovery Preclinical Development Clinical Development FDA Filing/ Approval & Launch Preparation Critical Path What’s the Critical Path? Critical Path is the FDA's premier initiative to identify and prioritize the most pressing medical product development problems and the greatest opportunities for rapid improvement in public health benefits.

16. CDRH Research Program(Efficient, Effective, and Predictable Product Development) High Intensity Focused Ultrasound (HIFU) ISSUE The lack of standardized methods to assess the acoustic and thermal characteristics of the focused beams ACCOMPLISHMENTS In a device for the ablation of uterine fibroids, CDRH-developed computational modeling to predict the performance of the device under conditions that would have been difficult to investigate experimentally, thus shortening the review time

17. Display evaluation: physical characterization and observer studies High-performance computing X-ray, electron, and photon transport simulation Colonic polyp CAD Computer phantom of cardiovascular disease Tomosynthesis Cone-beam CT detector scanning x-ray tube q planes of reconstruction Computer-aided immunohistochemical imaging Bone sonometry Medical Imaging and Diagnostics LaboratoryDIAM, OSEL CDRH, FDAandNIBIB/CDRH Laboratory for the Assessment of Medical Imaging Systems Feb. 06

18. Test methods for Optical Coherence Tomography (OCT) devices Imaging OCT point spread function with nanoparticles Computational modeling of fiber-optic probe designs used in fluorescence-based neoplasia detection Characterization of Optical Diagnostic Device Performance Depth 1 mm

19. Pregnant Women Exposed to Hand Held Metal Detectors

20. Information Technology Using and Developing Improved IT Systems put into production in 2005 and 2006: • Three CTS (Center Tracking System) “subsystems” • Device Nomenclature Management System (DNMS) • Condition of Approval Tracking System (COATS) • eConsult • OIVD Turbo 510(k) Systems under development: • eMDR (electronic submittal receipt of adverse event reports) • PPOMP (Pre-market Program Operations Modernization Project) • OC Tracking – This will also be a “subsystem” within CTS