Medical devices, the FDA, and the home healthcare clinician

Lisa K Simone¹, JoAnn Brumbaugh, Catherine Ricketts

• ¹Lisa K. Simone, PhD, MS-MOT, is a Biomedical Engineer, Division of Electrical and Software Engineering, Office of Science and Engineering Laboratories, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland. JoAnn Brumbaugh, BSN, RN, LNC, is a Nurse Consultant, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S Food and Drug Administration, Silver Spring, Maryland. Catherine Ricketts, BSN, RN, is a Nurse Consultant, Division of Postmarket Surveillance, Office of Surveillance and Biometrics, Center for Devices and Radiological Health, U.S. Food and Drug Administration, Silver Spring, Maryland.