"Draft" guidance documents will not be usable by reviewers under CDRH policy.
This article was originally published in The Gray Sheet
"DRAFT" GUIDANCE DOCUMENTS WILL NOT BE USABLE BY CDRH REVIEWERS under the interim guidance development policy expected to be implemented by the FDA Center for Devices and Radiological Health in the coming weeks. Currently, CDRH maintains most guidance documents in permanent "draft" status, dated at the time of issuance. The interim policy will mandate that guidance documents intended for use by reviewers must be issued in final form with an effective date. If a guidance is labeled "draft," it will denote that it is not yet in use by reviewers.
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