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Zdrowie i gospodarka · 28.03.2011

Clarifying Edits to Existing Special Controls Guidance Documents; Availability

The Food and Drug Administration (FDA) is announcing the availability of updated special controls guidance documents for class II devices, which contain edits that reflect the Agency's effort to clarify questions and confusion regarding its position on the binding nature of special controls guidance documents. The revised language does not change the Agency's position or view, but rather is intended to clarify its position and remedy any possible confusion or misunderstanding.

Source: Federal Register — Health and Human ServicesOpen original release →