- HCT/P Establishments (Mandatory Reporting)
- Health Care Professionals, Patients and Consumers (Voluntary Reporting)
For HCT/P Establishments (Mandatory Reporting)
On November 24, 2004, the Food and Drug Administration published a final rule that includes requirements in 21 CFR Part 1271.350(a) for reporting certain adverse reactions related to implantation, transplantation, infusion, or transfer of an HCT/P. This rule was effective on May 25, 2005 for HCT/Ps procured on or after the effective date.
HCT/P establishments must maintain complaint files and evaluate each complaint relating to core CGTP requirements.
Establishments are required to:
- Investigate any adverse reaction involving a communicable disease related to an HCT/P they made available for distribution and
- Report to FDA any serious adverse reactions involving a communicable disease if it is:
- Is fatal
- Is life-threatening
- Results in permanent impairment of a body function or permanent damage to body structure or
- Necessitates medical or surgical intervention, including hospitalization.
The establishments are required to use the FDA MedWatch mandatory reporting form (Form FDA-3500A) and submit each report to FDA within 15 days of initial receipt of the information. This is the first federal requirement for reporting of adverse reactions from transplanted HCT/Ps.
When reporting an HCT/P adverse reaction please fill out Section C. Suspect Products unless you know that the HCT/P is regulated as a Medical Device, then report in Section D.
- Form FDA 3500A - Mandatory Reporting was revised 2/2013
The guidance document provides specific information that will assist HCT/P establishments in reporting to FDA using the MedWatch Form FDA 3500A. The Standard Operating Procedure is utilized by FDA in investigating certain adverse reaction reports.
- Guidance for Industry: 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 - 3/2016
- CBER SOPP 8508 - Procedures for Handling Adverse Reaction Reports Related to "361" Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)
For Health Care Professionals, Patients and Consumers (Voluntary Reporting)
FDA encourages voluntary reports of HCT/P adverse reactions by health care professionals, patients and consumers to MedWatch. Voluntary reporters may use MedWatch Form FDA 3500 for reporting (see below).
When reporting an HCT/P adverse reaction:
- Please fill out Section D. Suspect Products (not Section E. Suspect Medical Device)
- Please provide as much information about the HCT/P as you can
- Name/Type of HCT/P (ex. Achilles Tendon)
- Name of HCT/P distributor or processor
- Lot number, HCT/P Distinct Identification Code
Voluntary reporters may submit the information online to FDA through the MedWatch Online Voluntary Form (3500). The MedWatch Online application uses Secure Socket Layers (SSL) and Pretty Good Protection (PGP) to encrypt and ensure the security and confidentiality of the MedWatch submission across the Internet.
MedWatch Form FDA 3500 is available for download for voluntary reporters. The form can be submitted by fax or mailed to FDA.
Reporting can also be accomplished by calling 1-800-FDA-1088.
Questions concerning reporting HCT/P adverse reactions may be sent to TST@cber.fda.gov.
FDA Reporting instructions for Health Care Professionals
FDA Reporting instructions for Consumers
On July 1, 2005, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) tissue standards went into effect for any JCAHO accredited organization which stores or issues tissues. These standards include a requirement to report tissue adverse reactions.
All adverse reactions involving tissues, including disease transmission or other complications suspected of being directly related to tissue use, are to be investigated and reported to the HCT/P establishment from which the tissue was received. More information is available on the the JCAHO web site.