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Zdrowie i gospodarka · 29.12.1995

Orthopedic Devices: Classification, Reclassification, and Codification of Pedicle Screw Spinal Systems; Extension of Comment Period

The Food and Drug Administration (FDA) is extending to March 4, 1996, the comment period for the proposed rule that published in the Federal Register of October 4, 1995 (60 FR 51946). The document proposed to classify certain unclassified preamendments pedicle screw spinal systems into class II (special controls), and to reclassify certain postamendments pedicle screw spinal systems from class III (premarket approval) to class II. FDA is taking this action in response to several requests for an extension to assure adequate time for preparation of comments.

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