Enhancing Staff Training for New Medical Device Reviewers

Transcription

1 Enhancing Staff Training for New Medical Device Reviewers Carole C. Carey, BSEE, MEng. Center for Devices and Radiological Health U.S. Food and Drug Administration

2 TOPICS Addressing CDRH 2011 strategic priority strengthen workforce / enhance staff training What is CDRH Staff College? who they are and their role in the Center Introduce the two new training programs in CDRH currently, for new reviewers, who engage in the reviews of premarketing submissions. 2

3 CDRH 2011 Strategic Priorities 1. Fully Implement a Total Product Life Cycle Approach 2. Enhance Communication and Transparency 3. Strengthen our Workforce and Workplace 4. Proactively Facilitate Innovation and Address Unmet Public Health Needs 3

4 Enhance Staff Training One of the 25 CDRH action items in the FDA s Implementation of 510(k) and Science Recommendations is to develop and implement training on core competencies. Increase predictability and transparency of regulatory pathways. Strengthen the premarket notification or 510(k) process. Improve consistency of medical device reviews and premarketing applications. 4

5 What is the CDRH Staff College? Where Learning Meets Opportunity

6 CDRH Staff College Center s resource for Scientific and Regulatory Training Management and Leadership Training and Development Career Development Programs Customized Learning Opportunities in support of CDRH mission and Center s TPLC (total product life cycle) program initiatives. Skilled training and technology professionals Partner with Center Offices and Business Entities Design and Deliver Valuable Learning Products and Services 6

7 CDRH Staff College features Calendar of Events Staff College Weekly Course Announcements Class Registration* Transcripts* Classrooms are located at FDA White Oak Campus *Registration and Transcripts accessed through an on-line portal using the Learning Management System 7

8 FDA News & Events: News Release For Immediate Release: Sept 6, 2011 FDA announces new staff training for medical device reviewers Training a key step to improving device review program, strategic priorities. 8

9 Two New Reviewer Training Programs Reviewer Certification Program (RCP) Experiential Learning Program (ELP) (in the design stage) 9

10 Reviewer Certification Program A structured, comprehensive training program to address basic core competencies for premarket reviewers Began as a pilot program in April 2010 Division of Anesthesia, General Hospital, Infection Control and Dental Devices Recently launched September 2011 All new premarket device reviewers Mandatory 18 months of training 10

11 Objectives Critical Thinking Problem Solving Organizational Knowledge Information Technology Enhance knowledge, skills and abilities that new reviewers bring to CDRH. Provide the resources to facilitate a smooth transition in their role as pre-market scientific reviewers. We are investing resources so that new device reviewers at CDRH are equipped to handle the range of issues that arise during the premarket device reviews, said CDRH director Jeffrey Shuren, M.D. This investment will improve the quality of submission review and make the process more consistent and predictable. 11

12 Methodology Basic core courses Classroom setting, instructor-led courses On-line (webcasts), self-paced training module Build upon knowledge learned in previous classes. Practical experience (Hands-on) in the medical device review process Apply competencies learned in classroom and on-line courses Knowledge assessment Exam Practical activity with an audit component 12

13 Core Subject Matter food and drug law, medical device law and regulatory requirements the CDRH review process (e.g. 510(k), IDE, PMA) using tools such as guidance documents, standards, templates, etc. writing memos, deficiencies and consulting reviews communication skills risk communication devices design and the impact of human factors Center information technology courses 13

14 Experiential Learning Program In development stage Practical experience that will include visits to universities, research organizations, manufacturers and health care facilities Scheduled to begin in 2012 as a pilot program 14

15 Objectives Provide a better understanding of how medical devices are designed, manufactured and used. Help understand the challenges of technology development and the impact of medical devices on patient care. Providing our review staff with opportunities to experience medical device development and use from outside the agency will provide new reviewers with a broader view of the regulatory process for medical devices (Dr. Jeffrey Shuren, CDRH Director) 15

16 Summary The two CDRH new training programs are designed to improve consistency, quality and predictability of medical device reviews Reviewer Certification Program Experiential Learning Program As technology keeps advancing in a rapid pace and medical device reviews are becoming more complex, CDRH Staff College is committed to leverage internal and external resources to enhance Center staff education, training and experience. 16

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