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Zdrowie i gospodarka · 25.09.2014

Policy Clarification for Fluoroscopic Equipment Requirements; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Policy Clarification for Fluoroscopic Equipment Requirements." This draft guidance describes FDA's intent to clarify the application of certain aspects of the performance standard requirements for fluoroscopic equipment when manufacturers comply with certain International Electrotechnical Commission (IEC) standards. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →