Why consider sex differences in Medical Device Reporting? The US Food and Drug Administration issue a draft guidance informed by two workshops, “Evaluation of Sex Differences in Medical Device Clinical Studies,” held in 2008. The FDA stated that “certain medical products elicit different responses in women compared to men. Differences may be attributable to intrinsic [...]
Read More medical devicesDraft Guidance for Industry and Food and Drug Administration Evaluation of Sex Differences in Medical Device Clinical Studies This guidance document is being distributed for comment purposes only. Document issued on: December 19, 2011 Table of Contents Preface INTRODUCTION SCOPE FOREWORD WHY CONSIDER SEX DIFFERENCES? PARTICIPATION OF WOMEN IN CLINICAL STUDIES Lack of [...]
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The Food and Drug Administration (FDA) repeatedly failed to hold cardiac device manufacturers to government standards for demonstrating safety and efficacy in women as well as men, according to a study published in Circulation and Cardiovascular QualityOutcomes. In effect, the FDA has approved implantable and other cardiovascular devices with out requiring the requisite data [...]
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