Opportunity Knocks: FDA/CDRH Medical Device Fellowship and External Expertise

Transcription

1 Opportunity Knocks: FDA/CDRH Medical Device Fellowship and External Expertise Nancy J. Pluhowski Director, Office of the Center Director Center for Devices and Radiological Health (CDRH), FDA Stanford University A Total Product Lifecycle Approach to Medical Device Development: Responsibilities and Opportunities September 2010

2 Disclaimer This communication does not constitute a written advisory opinion under 21 CFR 10.85, but rather is an informal communication under 21 CFR 10.85(k) which represents the best judgment of the employee providing it. This information does not necessarily represent the formal position of FDA, and does not bind or otherwise obligate or commit the agency to the views expressed. September,

3 CDRH (EEP): What We Do in EEP EEP provides guidance and assistance to CDRH to: Identify the needs for expertise within CDRH Foster collaborations with experts in the medical community and academic institutions to fulfill expertise needs Establish technology transfer agreements to develop and formalize partnerships Administer the Critical Path Program within CDRH September,

4 Outline for Presentation Fellowship Programs CDRH s Medical Device Fellowship Program (MDFP) FDA Commissioner s Fellowship Program (CFP) FDA s Critical Path Program September,

5 Medical Device Fellowship Program (MDFP) EEP uses MDFP to expand CDRH s capacity to obtain the expertise required to regulate medical devices of ever-increasing complexity September,

6 Expertise at CDRH acquired through MDFP includes: Cardiothoracic Surgery Interventional Cardiology Electrophysiology Neurosurgery Pulmonology Gastroenterology Ophthalmology Internal Medicine Nephrology Plastic Surgery Psychiatry Orthopedic Surgery Obstetrician and Gynecology Biomedical Engineering Biology Chemistry Epidemiology Biostatistics Regulatory Law September,

7 Academic Institutions Fellows have come to CDRH from: Stanford University Harvard University Johns Hopkins University Cleveland Clinic University of Pittsburgh George Washington University University of Texas Health Sciences Center William and Mary Mayo Clinic University of North Carolina Syracuse University University of Maryland September,

8 MDFP Fellows from Stanford Univ. Project examples: Computational modeling for cardiovascular devices Applying regulatory device processes to dental amalgam MDFP Intern Projects September,

9 MDFP Fellows from Stanford Univ. Computational Modeling for Cardiovascular Devices CDRH in collaboration with Stanford, NHLBI, and NSF held a Critical Path Workshop on Use of Computational Modeling Techniques for Cardiovascular Device Development which identified the current challenges for this important area of cardiovascular medical device development September,

10 MDFP Fellows from Stanford Univ. Apply Regulatory Processes to Dental Amalgam Research and analyze comments from a 2002 proposed rule on dental amalgam Review and summarize comments from a 2008 Federal Register Notice of final rule on dental amalgam Serve as a medical device reviewer in the Dental Devices Branch September,

11 MDFP Fellows from Stanford Univ. Intern Project (example) Analyze adverse reports in the MAUDE database to help identify any specific issues related to the use of surgical mesh. The data will be analyzed for trends to determine patterns in specific product characteristics or categories that contribute significantly to adverse events September,

12 MDFP Fellows from Stanford Univ. Intern Project (example) Analyze adverse event data of MRI related thermal injuries, develop a scientific rationale for the occurrences, and determine suitable preventative measures September,

13 MDFP Fellows from Stanford Univ. Intern Project (example) Evaluate partnership opportunities in EEP and develop collaboration policy statements to help support public health initiatives Collect and analyze data from sources associated with each area of EEP - Critical Path, MDFP and Tech Transfer September,

14 Commissioner s Fellowship Program at FDA Engineering Candidates may have BS, MS, PhD or but all other candidates must have MD or PhD level Combination of project and required course work All fellows start as a cohort in October of each year Application period is January to March Website - go to find this link: uatefacultyprograms/commissionersfellowshipprogram/default.htm Or, search for CDRH preceptors to find a list of CDRH preceptors September,

15 Critical Path (CP) Program The goal of FDA s Critical Path Program is to identify and prioritize the most pressing problems in medical product development and the greatest opportunities for improvement in public health benefits Critical Path Opportunities Report path/ September,

16 Examples of CDRH CP Projects Leverage the Simulation-Based Engineering and Medical Imaging Technology GOAL: Promote the use of computational modeling in cardiovascular device design and address barriers and regulatory issues needed to implement modeling September,

17 Examples of CDRH CP Projects Conduct research to ultimately standardize CT Protocols for Imaging-based Measures of Disease Status in Lung Cancer GOAL: Improved use of CT for evaluating effect of therapy and drug trials for lung cancer September,

18 Examples of CDRH CP Projects Biomarkers of Acute Kidney Injury to Improve Public Health and Product Approval GOAL: Development of new biomarkers to detect acute kidney injury previous biomarkers detected damage when injury was severe September,

19 Examples of CDRH CP Projects Standardize Assessment of Impingement in Spinal Devices GOAL: Develop and validate impingement testing to better predict device success September,

20 Thank you! External Expertise and Partnerships Technology Transfer Medical Device Fellowship Program Critical Path Initiative