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Zdrowie i gospodarka · 7.02.2002

Draft Guidance for Industry and FDA on Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Availability

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device." This draft guidance is intended to support the classification of the resorbable calcium salt bone void filler device. Elsewhere in this issue of the Federal Register, FDA is issuing a proposed rule to classify the resorbable calcium salt bone void filler device into class II. This draft guidance is neither final nor is it in effect at this time.

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