Articles
Adverse Reactions Reporting for HCT/Ps
Mar 01, 2016
GUIDANCE FOR INDUSTRY
We, FDA, are issuing this guidance to provide establishments1 that manufacture human cells, tissues, and cellular and tissue-based products (HCT/Ps) with recommendations for complying with the requirements under Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271) for investigating and reporting adverse reactions involving communicable disease in recipients of HCT/Ps that are regulated solely under section 361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271 (hereafter referred to throughout this guidance as “361 HCT/Ps”. In addition, this guidance provides updated information specific to reporting adverse reactions related to HCT/Ps to supplement the general instructions accompanying the MedWatch mandatory reporting form, Form FDA 3500A.