Chapter
FDA WAS INCONSISTENT IN MEETING PERFORMANCE GOALS FOR PMAS WHILE FDA REVIEW TIME AND TIME TO FINAL DECISION GENERALLY INCREASED
FDA Met Most Goals for Original PMAs but Fell Short of Most Goals for Expedited PMAs from 2003-2010
FDA Review Time and Time to Final Decision Generally Increased for PMAs from 2003 to 2010
The Average Number of Review Cycles Increased for Certain PMAs While the Percentage of PMAs Approved after One Review Cycle Generally Decreased
STAKEHOLDERS NOTED ISSUES WITH THE MEDICAL DEVICE REVIEW PROCESS; FDA IS TAKING STEPS THAT MAY ADDRESS MANY OF THESE ISSUES
Stakeholders Cite Insufficient Communication between FDA and Stakeholders throughout the Review Process
Industry Stakeholders Report a Lack of Predictability and Consistency in Reviews
Industry Stakeholders Note an Increase in Time to Final Decision
Consumer Advocacy Group Stakeholders Suggest That FDA Provides Inadequate Assurance of the Safety and Effectiveness of Approved or Cleared Devices
APPENDIX I: FDA MEDICAL DEVICE REVIEW PERFORMANCE FOR FISCAL YEARS (FY) 2000–2011
APPENDIX II: NUMBER OF FULL-TIME EQUIVALENT (FTE) FDA STAFF SUPPORTING MEDICAL DEVICE USER FEE ACTIVITIES, FYS 2003 THROUGH 2010
Chapter 2 PEDIATRIC MEDICAL DEVICES: PROVISIONS SUPPORT DEVELOPMENT, BUT BETTER DATA NEEDED FOR REQUIRED REPORTING
Medical Device Premarket Review Process
Pediatric Populations for Medical Devices
FDAAA Provisions on Pediatric Medical Device Development
CHARACTERISTICS OF THE POPULATION AND LIMITED ECONOMIC INCENTIVES CITED AS BARRIERS TO PEDIATRIC DEVICE DEVELOPMENT
PEDIATRIC DEVICE CONSORTIA HAVE ASSISTED OVER 100 DEVICE PROJECTS; MANY WERE IN EARLY DEVELOPMENT
FDA LACKS RELIABLE INFORMATION TO READILY IDENTIFY ALL PEDIATRIC PMA AND HDE DEVICES
FDA Has Not Consistently Collected Reliable and Timely Information Needed to Report on Pediatric Devices
RECOMMENDATION FOR EXECUTIVE ACTION
APPENDIX I: SUMMARY OF HDE DEVICES GRANTED EXEMPTION FROM THE HDE PROFIT PROHIBITION
SUMMARY OF PEDIATRIC HDE DEVICES EXEMPT FROM THE HDE PROFIT PROHIBITION
SURVEY OF PHYSICIANS AND HOSPITALS THAT HAVE USED THE MELODY TPV
APPENDIX II: PMA AND HDE DEVICES EXPLICITLY INDICATED FOR USE IN PEDIATRIC PATIENTS SINCE FISCAL YEAR 2006
APPENDIX III: PMA AND HDE DEVICES EXPLICITLY INDICATED FOR USE IN PEDIATRIC PATIENTS, FISCAL YEARS 2008 THROUGH 2011
End Notes for Appendix II
Chapter 3 MEDICAL DEVICES:FDA'S PREMARKET REVIEW AND POSTMARKET SAFEY EFFORTSTESTIMONY OF MARCIA CROSSE, GOVERNMENT ACCOUNTABILITY OFFICE, DELIVERED AT THE HEARING ON ''A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL PROCESS''
Premarket Review of Medical Devices
Postmarket Oversight of Voluntary Medical Device Recalls
FDA HAS TAKEN SOME ACTIONS IN RESPONSE TO OUR RECOMMENDATION TO STRENGTHEN THE PREMARKET REVIEW PROCESS, BUT CONCERNS ABOUT THE 510(K) PROCESS REMAIN
SHORTCOMINGS IN FDA’S OVERSIGHT OF THE HIGHEST-RISK MEDICAL DEVICE RECALLS INCREASE THE RISK THAT UNSAFE DEVICES CONTINUE TO BE USED
FDA Has Not Routinely Used Recall Data to Aid Its Oversight of the Recall Process
FDA Inconsistently Assessed the Effectiveness of Recalls
FDA Lacks Specific Criteria to Determine Whether Firms Have Taken Adequate Steps to Correct or Remove Recalled Devices
FDA’s Recall Termination Process Is Compromised by Weak Procedures and May Result in Recalled Medical Devices Remaining on the Market
Chapter 4 STATEMENT OF WILLIAM MAISEL, DEPUTY DIRECTOR FOR SCIENCE, CENTER FOR DEVICES AND RADIOLOGICAL HEALTH, FOOD AND DRUG ADMINISTRATION, HEARING ON ''A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL PROCESS''
IMPROVEMENTS TO THE 510(K) PROGRAM
MEDICAL DEVICE USER FEE ACT PERFORMANCE
POST-MARKET SURVEILLANCE ACTIVITIES
Mandated Post-market Studies
Role of Industry in Recalls
Medical Device Epidemiology Network (MDEpiNet)
Unique Device Identification (UDI)
Government Accountability Office (GAO) Evaluations
Chapter 5 TESTIMONY OF DAVID NEXON, SENIOR EXECUTIVE VICE PRESIDENT, ADVANCED MEDICAL TECHNOLOGY ASSOCIATION, HEARING ON ''A DELICATE BALANCE: FDA AND THE REFORM OF THE MEDICAL DEVICE APPROVAL PROCESS''
THE U.S. MEDICAL TECHNOLOGY INDUSTRY
FDA’S 510(K) PROCESS FOR PRE-MARKET REVIEW
FDA’S POST-MARKET AUTHORITY FOR MEDICAL DEVICES
FDA Oversight of Medical Devices: Efforts and Developments
( Medical Devices and Equipment )
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