An FDA Viewpoint on Unique Considerations for Medical-Device Clinical Trials

Although devices are manufactured and marketed worldwide, this review focuses on the strategy used by the U.S. Food and Drug Administration (FDA); special attention is paid to the ways in which the evaluation of devices is distinct from that of drugs. The entry of the FDA into the device arena was largely prompted by several deaths and claims by an estimated 200,000 women that they were harmed by the use of the Dalkon Shield, an intrauterine device (IUD) intended for contraception. Women who used this device had five times the risk of pelvic inflammatory disease as those using other IUD types, and several had uterine rupture or septic pregnancies. Congress responded by passing the Medical Device Amendments to the Food, Drug, and Cosmetic Act.1,2 These 1976 amendments established a risk-based regulatory framework for evaluating medical devices in the United States. Under this framework, the requirements that a device must meet to be lawfully marketed depend on the risk classification of the product, with risk being assessed as the potential for the device to present harm to the patient, including in circumstances in which the device could malfunction or be used improperly.

Most low-risk devices, which present a minimal potential for harm to the user (e.g., prescription eyeglasses, elastic bandages, and dental floss), are exempt from FDA review before marketing, although manufacturers are still subject to certain requirements. Manufacturers of most moderate-risk devices, such as condoms, nebulizers, and blood glucose meters, generally need to show that their device is substantially equivalent to another device already cleared by the FDA; in most cases, this is achieved through bench (nonclinical laboratory) testing and without clinical data.3 Higher-risk and innovative moderate-risk devices (approximately 4% of all medical devices), which are the primary focus of this article, generally require clinical evidence to show that the benefits of a technology outweigh its risks. Such information is often critical not only for showing the safety and effectiveness of the device but also for informing clinicians and patients about the preferred use of the device in the marketed clinical setting. This article seeks to illustrate the broad array of trial designs and clinical data sources that may be used to support the safety and effectiveness of these critical products.

Thank You!!!

For More Details Medical Device Animation