About FDA

How does FDA regulate tissue products? What safeguards are in place for recipients?

FDA regulates human cells or tissues intended for implantation, transplantation, infusion, or transfer into human recipients. These are referred to as human cells, tissue, and cellular and tissue-based products, or HCT/Ps. Examples of HCT/Ps include

  • bone
  • skin
  • corneas
  • ligaments
  • tendons
  • dura mater
  • heart valves
  • cell-based products
  • reproductive tissues including oocytes and semen

FDA focuses on three general areas of regulation:

  1. limiting the risk that a communicable disease may be transferred from a cell or tissue donor to the recipient
  2. establishing manufacturing practices that minimize the risk that cell or tissue products will be contaminated
  3. requiring cells and tissues that present greater risks due to their processing or their use to demonstrate safety and effectiveness

FDA does not regulate the transplantation of human organs containing blood vessels (such as kidney, liver, heart, lung or pancreas). The Health Resources Services Administration oversees human organs.

Rate this page

1 (Not Helpful) → 5 (Very Helpful)

(Limit your feedback to 1000 characters.)

(Limit your feedback to 1000 characters.)

If you would like to ask a specific question, please visit our "Contact Us" page for more information about how to contact FDA.

Please note that any information you submit may become public or subject to release under the Freedom of Information Act (FOIA). For more information, read about our privacy policies and the FOIA.

Page Last Updated: 09/03/2015
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.