Fuerst Ittleman is emerging as the leading U.S. law firm in assisting clients with compliance with the regulation of human cellular and tissue-based products (HCT/Ps). These products are regulated by the Food and Drug Administration as traditional biological products, drugs, devices, or solely under the HCT/Ps regulatory structure of 21 C.F.R. § 1271.
Fuerst Ittleman has experience in navigating the intricacies of the FDA regulatory structure for HCT/Ps. We also help clients comply with the American Association of Blood Banks Standards for Cellular Therapies and corresponding state laws.
Fuerst Ittleman has assisted clients by determining which regulation applies to their HCT/Ps, premarket reviews, establishment registration and listing of the HCT/Ps on the FDA website, preparation for establishment inspections, and the import and export of HCT/Ps. We have experience reviewing and compiling standard operating procedures for clients to ensure compliance with FDA regulations for donor screening and testing, Good Tissue Practices, labeling and tracking of HCT/Ps, record keeping, and adverse event reporting requirements. We also help clients with the promotion and advertising of their HCT/Ps and HCT/P services to ensure proper classification under the regulations.
For more information for how we can assist with you HCT/Ps, please contact us at contact@fuerstlaw.com or (305) 350-5690.
