Journal-based CME Course: How Should Clinicians and Organizations Assess Risks and Benefits of First-in-Human Implantation of Investigational Devices?

Activity ID

10816

Expires

August 6, 2027

Format Type

Journal-based

CME Credit

Fee

$30

CME Provider: AMA Journal of Ethics

Description of CME Course

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 post market 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.

Disclaimers

1. This activity is accredited by the American Medical Association.
2. This activity is free to AMA members.

ABMS Member Board Approvals by Type

ABMS Lifelong Learning CME Activity

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More Information

Commercial Support?

NOTE: If a Member Board has not deemed this activity for MOC approval as an accredited CME activity, this activity may count toward an ABMS Member Board’s general CME requirement. Please refer directly to your Member Board’s MOC Part II Lifelong Learning and Self-Assessment Program Requirements.

General Information on CME Activity

Educational Objectives

1. Explain a new or unfamiliar viewpoint on a topic of ethical or professional conduct
2. Evaluate the usefulness of this information for health care practice, teaching, or conduct
3. Decide whether and when to apply the new information to health care practice, teaching, or conduct

Keywords

Ethics, Medical Devices and Equipment, Shared Decision Making and Communication

Competencies

Medical Knowledge, Professionalism

CME Credit Type

AMA PRA Category 1 Credit

DOI

10.1001/amajethics.2021.673