Establishments that manufacture human cells, tissues, and cellular and tissue-based products have to comply with a number of requirements under Title 21 of the Code of Federal Regulations Part 1271 (21 CFR Part 1271). This includes investigating and reporting adverse reactions in recipients of cellular and tissue-based products. The present guidance, published by the FDA in spring, is meant to help these establishments or manufacturers to do this in compliance with the requirements. This guidance applies to all establishments that manufacture non-reproductive HCT/Ps according to part 361of the Public Health Service Act (PHS Act).
When final, this guidance will supplement the "Guidance for Industry: Current Good Tissue Practice (CGTP) and Additional Requirements for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" from the year 2011, by providing additional recommendations specific to the responsibilities when investigating adverse reactions.
In addition, the guidance provides information on the general instructions accompanying the "MedWatch mandatory reporting form, Form FDA 3500A" and will supersede the guidance entitled "Guidance for Industry: MedWatch Form FDA 3500A: Mandatory Reporting of Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" when finalized.
More details about the scope and the background can be read directly in the guidance "Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271".