Activity ID
10818Expires
August 6, 2027Format Type
Journal-basedCME Credit
1Fee
$30CME Provider: AMA Journal of Ethics
Description of CME Course
Many devices in current use were marketed before the US Food and Drug Administration (FDA) began regulating devices in 1976. Thus, manufacturers of these devices were not required to demonstrate safety and effectiveness, which presents both clinical and ethical problem for patients, especially for women, as some of the most dangerous devices such as implanted contraceptive devices are used only in women. This article investigates whether and to what extent devices for women receive less rigorous scrutiny than devices for men. This article also suggests how the FDA Center for Devices and Radiological Health could more effectively ensure safety and effectiveness of devices that were marketed prior to 1976.
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
Allergy and Immunology
Anesthesiology
Colon and Rectal Surgery
Family Medicine
Medical Genetics and Genomics
Nuclear Medicine
Ophthalmology
Orthopaedic Surgery
Pathology
Physical Medicine and Rehabilitation
Plastic Surgery
Preventive Medicine
Psychiatry and Neurology
Radiology
Thoracic Surgery
Urology
Commercial Support?
NoNOTE: 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.
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, Regulatory Agencies, Medical Devices and Equipment
Competencies
Medical Knowledge, Professionalism
CME Credit Type
AMA PRA Category 1 Credit
DOI
10.1001/amajethics.2021.750
