How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?
| Autor: | Beatrice L. Brown, Aaron S. Kesselheim |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Health (social science) business.industry United States Food and Drug Administration Health Policy Communication First in human Risk Assessment United States Food and drug administration Issues ethics and legal aspects Device Approval Product Surveillance Postmarketing Medicine Humans Risks and benefits business Intensive care medicine Clearance |
| Zdroj: | AMA journal of ethics. 23(9) |
| ISSN: | 2376-6980 |
| Popis: | The number of new medical devices cleared by the US Food and Drug Administration (FDA) through the 510(k) pathway that has subsequently been associated with safety risks has led to discussion of approaches to regulation and communication of device risks. As debate continues over whether the pathway needs to be altered, features of ethical use of 510(k)-cleared devices can include (1) heightened caution with respect to newly cleared 510(k) products until adequate data are gathered through postmarket surveillance, (2) facilitating informed consent by improving physician and patient knowledge of the 510(k) pathway, and (3) basing distribution of these devices on individual risk assessments while ensuring equitable access. |
| Databáze: | OpenAIRE |
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