Does 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?
About the Author
Audrey Swearingen is Director of Regulatory Affairs at Emergo's Austin, Texas headquarters. With over 20 years of experience in regulatory affairs, Audrey’s areas of expertise include US FDA medical device registration as well as European and Canadian device registration.