Clinical Performance Assessment CADe 510(k) Submissions Guidance
Cited by The Food and Drug Administration (FDA) on
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. FDA is responsible for, among many things, protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation.