Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.|Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.|Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.|Office of Surveillance and Biometrics, Center for Devices and Radiological Health, Food and Drug Administration, USA.