Safety and Efficacy of Orthopaedic Surgical Devices under the FDA's Updated Premarket Notification Program

By Griffin, Frank | Missouri Law Review, Summer 2019 | Go to article overview

Safety and Efficacy of Orthopaedic Surgical Devices under the FDA's Updated Premarket Notification Program


Griffin, Frank, Missouri Law Review


"The enemy of good is better." (1)  
TABLE OF CONTENTS  ABSTRACT                                                            779   I. INTRODUCTION                                                   781  II. FDA'S RECENT CHANGES TO THE 510(K) PATHWAY                     783      A. Increased Premarket Expectations for 510(k) Submissions     783         1. More pages of paperwork                                  783         2. Incorporation of Benefit/Risk factors                    784      B. Refuse-To-Accept Policy                                     785      C. Improved Consistency and Thoroughness                       785      D. Elimination of 510(k) for Class III Devices                 786      E. Elimination of More Than 1000 Devices as Legal Predicates   788 III. ORTHOPAEDIC IMPLANTS, 510(K), AND LIKELY EFFECTS OF FDA        788      CHANGES      A. 510(k) and Orthopaedic Implants                             788         1. The 510(k) facilitated orthopaedic device "races"        788         2. 510(k)'s Facilitation of Outlier Device Approval         793         3. Back to the Future: Orthopaedic Device Predicates Are    795            Often Better Than Their 510(k) Descendants      B. Analysis of FDA's Recent 510(k) Changes on Orthopaedic      798         Device Outcomes         1. Things that did not change                               798         2. Things that have changed: Numerous Holes in the          800            November 2018 Changes            a. Increased Premarket Expectations for 510(k)           800               Submissions            b. Refuse-To-Accept Policy                               805            c. Improved Consistency and Thoroughness                 805            d. Elimination of 510(k) for Class III Devices           806            e. Elimination of More Than 1000 Devices as Legal        807               Predicates  IV. ADDITIONAL PROPOSED SOLUTIONS                                  808      A. Regulatory Changes by the FDA                               808      B. Ensuring Fairness in Medical Device-Related Trials          810         1. State Tort Law: Informed Consent                         810         2. Ensuring a Fair Trial Under Daubert in Medical Device    813            Cases            a. A Balanced Approach to Expert Testimony: Stop         814               Favoring Insider Defendants' Experts with Conflicts               of Interest and Disfavoring Plaintiffs' Experts            b. Stop Blame-Shifting Liability onto Hospitals and      816               Doctors for Poorly Performing 510(k) Devices      C. Congressional Action                                        817         1. Introduction of a "Medicare 510(k) Payment Reduction     817            Program"         2. Start "MedicalDeviceCompare.gov" to Give the Public      822            Access to Clearance Pathway Information and Statistics         3. Medicare Should Make Sure Future Doctors Are Trained     823            Preferentially Using Proven Medical Devices V. CONCLUSION                                                       827 APPENDIX A: ESTIMATED NUMBERS OF TKAS PERFORMED IN THE U.S.         828 

I. INTRODUCTION

Orthopaedic surgical devices are recalled 11.5 times more commonly when they obtain FDA clearance by Premarket Notification ("510(k)") than when they are cleared via the more vigorous Premarket Approval ("PMA") review. (2) Recall of implanted orthopaedic devices that have been affixed to or implanted within a large bone, like the femur, can be devastating for patients--especially if the device must be removed or revised. For example, Medicare patients undergoing revision total hip replacements are at risk for infection (17.3%), blood clots (i.e., venous thromboembolic disease; 11.1%), dislocation (5.43%), pulmonary embolism (3.24%), and death (2.11%). (3) Due to the significant potential for life-altering consequences of revision of recalled medical devices affixed to or implanted within large bones, recall of orthopaedic devices is unacceptable and the FDA should optimize orthopaedic device clearance pathways to minimize the chances that approved devices will later be recalled. …

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Safety and Efficacy of Orthopaedic Surgical Devices under the FDA's Updated Premarket Notification Program
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