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Condition of Approval Studies: Recent Changes in CDRH

Condition of Approval Studies: Recent Changes in CDRH. Susan Gardner, PhD Director, Office of Surveillance and Biometrics, CDRH Advisory Panel. Office of Surveillance and Biometrics: Basic Functions. Premarket review Statisticians Epidemiologists

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Condition of Approval Studies: Recent Changes in CDRH

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  1. Condition of Approval Studies: Recent Changes in CDRH Susan Gardner, PhD Director, Office of Surveillance and Biometrics, CDRH Advisory Panel

  2. Office of Surveillance and Biometrics: Basic Functions • Premarket review • Statisticians • Epidemiologists • Signal detection via monitoring tools including MDR, MedSun • Risk characterization (analysis) • Coordination of Center response • Interpretation of MDR regulation

  3. Condition of Approval Studies • Postapproval requirements can include “continuing evaluation and periodic reporting on the safety, effectiveness, and reliability of the device for its intended use.” 21 CFR 814.82 (a) (2).

  4. Internal Evaluation of CoA Program • 1998 through 2000: 127 PMAs approved with 45 CoA orders. • CDRH had limited procedures for tracking progress or results • Turnover of lead reviewers resulted in lack of follow-up • Lack of premarket resources

  5. Strategy for Change • GOAL: • Obtain postmarket information as device enters the market to continue to assure the safety and effectiveness of the device in “real world” use • Better characterize the risk benefit profile • Add to our ability to make sound scientific decisions

  6. Strategy for Change • Transfer CoA program to OSB (1/1/05) • Develop and institute an automated tracking system for CoA commitments • Acknowledge the receipt of study reports • Follow-up when reports are not received

  7. Strategy for Change • Add epidemiologist to PMA review team • Tasked with the development of a postmarket monitoring plan during premarket review • Lead in developing well formulated postmarket questions • Lead in the design of CoA study protocol • Lead in evaluation of study progress and results after approval • Will continue to work with PMA team throughout

  8. Motivation for Study Conduct • Important postmarket questions and good study protocol design • Acknowledgement and feedback on studies • Posting of study status on CDRH website • Mandate postmarket study with penalties if not done.

  9. Impact on Advisory Panel • During approval process: we will attempt to lay out important post approval public health questions and possible approach for panel consideration. • During postmarket: FDA or industry will update the Advisory panel on the progress and results of CoA studies for approved devices.

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