Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Guidance for Industry; Availability
other · Food and Drug Administration · Rule · Published 2017-11-17 · 82 FR 54289
Document
Document number
2017-24839
Federal Register citation
82 FR 54289
CFR reference
21 CFR 1271
Type
Rule
Action
Notification of availability.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2017-11-17
HHS docket
Docket No. FDA-2014-D-1584
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a document entitled "Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception." The guidance document provides tissue establishments and health care professionals with FDA's current thinking on the scope of an exception set forth in the human cells, tissues, and cellular and tissue-based products (HCT/Ps) regulations.