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Business · 17/03/2004

FDA Releases Draft Guidance for External Penile Rigidity Devices

The Food and Drug Administration (FDA) has made available a draft guidance document outlining how external penile rigidity devices can meet the requirements for class II devices with special controls, as proposed in a separate rule announced in this issue of the Federal Register.

Original source language: Federal Register — Food and Drug AdministrationOpen original release →

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