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Imprese · 13/06/19971 min di lettura
Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers; Draft Guidance; Availability
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Riepilogo
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled, ``Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers.'' This draft guidance is intended to assist the manufacturer in preparing a complete 510(k) premarket notification submission to the Center for Devices and Radiological Health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 The agency is seeking public comment on the draft guidance.
Lingua originale della fonte: Federal Register — Food and Drug AdministrationApri il comunicato originale →