AMA Journal of Ethics

A history of device oversight by the US Food and Drug Administration traces regulatory changes in response to injuries caused by Dalkon Shield intrauterine devices.

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.

Lack of training and lack of knowledge can adversely influence a patient’s clinical outcomes.

If the safe-and-effective standard for judging devices’ potential as therapy or enhancement is inadequate, one might wonder whether BCI regulation should be overseen by the FDA.

Heightened caution, improved physician and patient communication, and equitable access are key priorities.

Device innovation has potential to improve patient outcomes over time, yet prospective benefits must be considered in light of risks.

Many devices in current use were marketed before manufacturers were required to demonstrate safety and effectiveness.

Physicians’ primary responsibility is to promote patients’ well-being, which includes not causing financial harm.

CEA has been increasingly used to inform public and private organizations’ reimbursement decisions, benefit designs, and price negotiations worldwide.

Insurers’ decisions about which services to cover are often based on economic models that are seemingly objective but neglect factors affecting people who are economically disadvantaged.