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Tissue Product or 510(k)/BLA? An overview of the FDA Regulations

  • Writer: Kaleidoscope Marketing
    Kaleidoscope Marketing
  • Mar 13
  • 2 min read

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In the world of biologics, understanding how the FDA classifies human-derived products is crucial. Whether a product is regulated as a tissue product or requires a 510(k) clearance or Biologics License Application (BLA) has significant implications for market entry, compliance, and commercialization strategy.

The FDA uses four key criteria to determine whether a product qualifies as a tissue product under the 21 CFR Part 1271 Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) regulations. These criteria were set forth in the document titled Guidance for Industry: Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps). If a product does not meet all four criteria, it likely must undergo additional regulatory pathways such as 510(k) or BLA approval.

The Four Key Criteria for Tissue Products

For a product to be regulated as an HCT/P without requiring a 510(k) or BLA, it must meet these four criteria:


  1. Minimal Manipulation

  2. Homologous Use

  3. Not Combined with Another Article (with limited exceptions)

  4. No Systemic Effect (with exceptions outside the scope of this discussion)



Let’s break these down further.


1. Minimal Manipulation

The FDA defines minimal manipulation differently for structural and non-structural tissues:


  • Structural Tissues: Processing must not alter the original relevant characteristics of the tissue related to its function in reconstruction, repair, or replacement.

  • Cells or Non-Structural Tissues: Processing must not alter relevant biological characteristics of the cells or tissues.


Examples of Minimal vs. More than Minimal Manipulation


  • Minimally ManipulatedAmniotic membrane packaged in sheets → Retains its natural barrier function.

  • More than Minimally ManipulatedAmnion ground into particles → Loses its ability to act as a barrier. Dermis ground into particles → No longer serves as a protective covering. Cartilage ground into particles → Loses its ability to absorb shock and reduce friction. Cell isolation and culture → Considered more than minimal manipulation.


2. Homologous Use

A product qualifies under homologous use if it performs the same basic function in the recipient as it did in the donor. This does not necessarily mean the tissue must be identical; rather, its primary function must remain unchanged.

Examples of Non-Homologous Use


  • A company markets an amniotic membrane product for wound healing or reducing inflammationProblem: Wound healing and inflammation reduction are not basic functions of amniotic membrane.

  • However, if the same amniotic membrane is marketed as a protective barrier, this can qualify as homologous use.


The FDA evaluates homologous use based on objective intent, which is determined by:


  • Manufacturer’s claims

  • Sales rep training

  • Website and marketing materials


3. Cannot Be Combined with Another Article

A tissue product cannot be combined with another substance unless it is an inert processing or preservation agent. For example, adding growth factors or drug components could disqualify a product from HCT/P classification.


4. No Systemic Effect

Generally, HCT/Ps must not have a systemic effect unless they meet specific exceptions (such as autologous cell therapies). Products intended to circulate through the body or trigger systemic responses typically require a BLA.

 
 
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