With a degree in management and marketing from Kansas State University, Kevin Lilly has spent the majority of his career in the healthcare technology sector. Most recently, Kevin Lilly was a senior vice president of sales at MiMedx, a biopharmaceutical company based in Marietta, Georgia. During his tenure with the company, he led the efforts to evolve the company in the HCT/P market.
HCT/Ps, as defined by the U.S. Food and Drug Administration, are human cell and tissue products. They are intended for medical use, primarily in surgery, transplantation, infusion, and implantation procedures, as well as genetic research and therapies. There are two main types of these products - 361 and 351.
When they meet Section 361 of the PHS Act and 21 CFR Section 1271.3 criteria, HCT/P products are regulated as 361 products. That means that they don’t need premarket approval. These products are mainly used in transplantation and implantation procedures.
On the other hand, products that are regulated under PHS Act section 351 are referred to as 351 products. These products are treated as biologicals, and are mainly used in gene and somatic cell therapies.
HCT/Ps, as defined by the U.S. Food and Drug Administration, are human cell and tissue products. They are intended for medical use, primarily in surgery, transplantation, infusion, and implantation procedures, as well as genetic research and therapies. There are two main types of these products - 361 and 351.
When they meet Section 361 of the PHS Act and 21 CFR Section 1271.3 criteria, HCT/P products are regulated as 361 products. That means that they don’t need premarket approval. These products are mainly used in transplantation and implantation procedures.
On the other hand, products that are regulated under PHS Act section 351 are referred to as 351 products. These products are treated as biologicals, and are mainly used in gene and somatic cell therapies.
