Compliance In Focus

In August, the FDA issued the final guidance document on Evaluation of Sex-Specific Data in Medical Device Clinical Studies. The intention of this guidance document is to improve the quality and consistency of available data regarding device performance in both sexes for devices that require clinical information in support of a marketing submission or post-approval/post-market surveillance submissions. The primary limitation on devices involves devices that are sex-specific; for instance, urology devices that are designed to be single-sex only.