About 10% of Americans will have a device implanted into their bodies during their lifetimes. Fewer than 0.5% of these devices, however, are likely to have been tested in rigorous clinical trials generally regarded as standard by US regulators. Despite looser regulation of materials and devices than for pharmaceuticals, clinician-investigators and the Food and Drug Administration are obligated to balance patient-subjects’ safety with demand for patients’ timely access to technologies and interventions that might improve or extend their lives. This issue investigates that tension.
Editorial fellow Dr Ariel Wampler describes what few know about material and device regulation, and Dr Adriane Fugh-Berman explains why we should ask more questions about device representatives’ intraoperative roles during implantations.
Beatrice L. Brown joins Ethics Talk to discuss her article, coauthored with Dr Aaron S Kesselheim: "How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?"