Skip to main content
. Author manuscript; available in PMC: 2018 Sep 1.
Published in final edited form as: Tech Shoulder Elb Surg. 2017 Sep 1;18(3):e6–e14. doi: 10.1097/BTE.0000000000000132

Table 3.

FDA regulatory categories.

Category 1 Category 2: Section 361 Category 3: Section 351
Oversight Level No HCT/P oversight Minimal Extensive Regulation
Product Risk Level Low Greater risk with regard to safety Greatest risk
Focus of the Regulations N/A Safety (preventing disease transmission) Safety and effectiveness.
Product Example Vascularized human organs for transplantation, whole blood and blood-derived products, and extracted human products such as collagen and bone marrow 99. Bone, cartilage, ligament, tendon, and skin 99. All other products
Establishment and/or Product Description An establishment that removes HCT/Ps from an individual and implants such HCT/Ps into the same individual during the same surgical procedure.
Products must be minimally manipulated, for homologous use and not combined with another article 99.		 The product must be:

  1. No more than minimally manipulated. For cells or nonstructural tissues, it means that there must be no change in the “relevant biological characteristics of cells or tissues” during processing, storage, etc.

  2. Used for a homologous purpose.

  3. Combined with no other cells, tissues, or articles except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that their addition poses no additional concerns regarding clinical safety.

  4. These products must also have either
    1. No systemic effect or otherwise depend on the metabolic activity of living cells for their primary function or
    2. A systemic effect or depend on the metabolic activity of living cells for their primary function. and for
      • Autologous use
      • Allogeneic use in a first- or second-degree blood relative. or
      • Reproductive use.
 The product is one or more of the following:

  1. More than minimally manipulated, which for cells and nonstructural tissue means to present a risk of change in cell morphology, function, expression, or other relevant biological characteristics during processing, storage, etc.

  2. Used for a nonhomologous purpose.

  3. Combined with other articles that may pose additional concerns regarding clinical safety.

  4. Have a systemic effect or otherwise rely on the metabolic activity of living cells for its primary function, and be used in a context other than autologous use, allogeneic use in a first or second degree relative, or reproductive use 98.
Main Regulatory Requirements Physicians must follow current Good Tissue Practices (cGTPs), but otherwise need not register as an establishment with the FDA’s CBER or submit a list of the HCT/Ps used. Physicians must employ current Good Tissue Practices (cGTPs), register their office or clinic as an “establishment” and submit an annually updated list of each HCT/P manufactured to CBER. They need not obtain premarketing approval before using the product or follow current Good Manufacturing Practices (cGMPs) in preparing them 99. Establishments must register and file a list of their HCT/Ps with CBER each year. Physician or clinic must complete the expensive process of obtaining formal premarket approval from the FDA (this can involve submitting a New Drug Application, an Investigational New Drug Application, Biologics License Application, or, when dealing with a Section 501k medical device, a premarket approval application or premarket notification). Physicians must follow the FDA-prescribed current Good Manufacturing Practices (cGMPs) and prescription drug labeling requirements that govern commercial pharmaceutical manufacturers.