US FDA Regulation of Human Cell and Tissue Products

Emergo White Paper - HOW THE FDA REGULATES MEDICAL PRODUCTS MADE OF HUMAN CELLS OR TISSUESDoes your medical device contain animal or donated human cells or tissues? If so, you must meet complex regulations before you can market your device in the United States.

US Food and Drug Administration regulations for such devices, commonly referred to as HCT/Ps (Human Cells, Tissues, and cellular and tissue-based Products), are daunting and any misstep in the regulatory process can be costly and delay the clearance of your device. In this whitepaper, we'll answer your biggest questions regulatory issues specific to HCT/Ps, including:

  • What is a HCT/P?
  • How does the US FDA regulate HCT/Ps?
  • How are HCT/Ps classified by the FDA?
  • What is Tissue Bank Establishment registration?

Learn all this and more in this 4-page white paper.

About the Author:
Audrey Swearingen is a Senior Global Regulatory Consultant with Emergo Group in Austin, Texas. She has worked in regulatory affairs for over 19 years at various medical device companies, most recently as a regulatory manager for Zimmer Orthobiologics. Audrey is on Google+.