We, FDA, are issuing this guidance to emphasize to you, establishments that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps), your responsibility to comply with Title 21 Code of Federal Regulations 1271.150(c)(1) (21 CFR 1271.150(c)(1)), if you enter into a contract, agreement, or other arrangement with another establishment to perform for you any step in manufacture. (Ref. 1). If you engage another establishment to perform for you any step in manufacture, that establishment must comply with requirements applicable to that manufacturing step (21 CFR 1271.150(c)(1)(i) and (ii)). The intent of this guidance is to highlight your responsibilities in ensuring that establishments that engage in any step in manufacture for you are in compliance with the current good tissue practice (CGTP) requirements of the HCT/P regulations in 21 CFR Part 1271.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.