Medical Gloves; Draft Guidance Manual; Availability; Extension of Comment Period

概要

The Food and Drug Administration (FDA) is extending to January 27, 2000, the comment period for the draft guidance entitled ``Medical Glove Guidance Manual.'' FDA published a notice of availability of the draft guidance in the Federal Register of July 30, 1999 (64 FR 41744). The agency is taking this action to harmonize the comment period for the draft guidance with the extension of the comment period for the proposed rule on the reclassification of surgeon's and patient examination gloves (64 FR 41710, July 30, 1999). The document announcing the extension of that comment period for the proposed rule is published elsewhere in this issue of the Federal Register. The draft guidance is a proposed special control for that reclassification. This extension of the comment period is intended to allow interested persons additional time to submit comments on the draft guidance.