Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance; Availability

Resumo

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, ``Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.'' This draft guidance is intended to assist the manufacturer in preparing a complete 510(k) premarket notification submission to the Center for Devices and Radiological Health (CDRH) or a third party reviewing organization. The agency is seeking public comment on the draft guidance.