ABSTRACT

Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health   [open pdf - 10MB]

"Medical devices play a crucial role in the treatment and diagnosis of illness and disease. They range from common medical supplies (bandages, hospital gowns) to complex instruments that help save and sustain life (heart valves, artificial pancreas). They include tools that aid in the detection of disease (MRIs [magnetic resonance imaging], in vitro diagnostics) and digital technology that is driving a revolution in health care (medical apps, surgical planning tools, closed loop drug delivery devices). [...] Although medical devices provide great benefits to patients, they also present risks. FDA's public health responsibilities span the life cycle of medical devices and, at every stage, FDA must make well-supported regulatory decisions, taking into account the totality of the evidence, to determine whether the benefits outweigh the risks."

Publisher:
Copyright:
Public Domain
Retrieved From:
U.S. Food and Drug Administration: https://www.fda.gov/
Format:
pdf
Media Type:
application/pdf
URL:
Help with citations