Medical Devices Draft Guidance on Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Guidance for Prescription Use Drugs of Abuse Assays Premarket Notifications." FDA is issuing this guidance to express the general principles FDA applies in evaluating premarket notifications (510(k)s) for prescription use drugs of abuse assays. The principles described in this draft guidance document apply only to in vitro diagnostic (IVD) submissions for 510(k) clearance for these devices. This draft guidance is neither final nor in effect at this time.