Understanding 361

Understanding 361

Regulatory Criteria for 361 Pathway

Definition

“As defined in 21 CFR 1271.3(f), minimal manipulation means 1) For structural tissue, processing that does not alter the original relevant characteristics of the tissue relating to the tissue’s utility for reconstruction, repair, or replacement; 2) For cells or nonstructural tissues, processing that does not alter the relevant biological characteristics of cells or tissues.”

Regenative’s Difference

Our proprietary process does not alter the original relevant characteristics of the tissue, nor does it involve the isolation of any components found within the original tissue. Our specialized technicians carefully resize and suspend the tissue in saline with added cryopreservative, which is expressly permitted by the FDA.

Objective Evidence

During our manufacturing process, the donated umbilical tissue, or Wharton’s jelly, is disassociated and reduced to a size that sufficiently maintains its ability to perform its primary structural function. Using Microscopy, the original relevant characteristics are observed in both the donor tissue and the final product.

FDA Literature and Examples

FDA Example – Pg. 7; III

Definitions

“As defined in 21 CFR 1271.3(c), homologous use means the repair, reconstruction, replacement, or supplementation of a recipient’s cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor.”

“In applying the homologous use criterion, the FDA will determine what the intended use of the HCT/P is, as reflected by the labeling, advertising, and other indications of a manufacturer’s objective intent, and will then apply the homologous use definition.”

Regenative’s Difference

The primary function of Wharton’s jelly is well established in scientific literature as providing cushioning and structural support. Wharton’s jelly in the umbilical cord serves to cushion and protect internal structures (the vein and arteries) from mechanical stress. When transplanted into a soft tissue defect, our product performs the same original functions as in the umbilical cord of cushioning and supporting surrounding tissues.

Objective Evidence

Regenative Labs has collected a significant amount of retrospective data which supports that our Wharton’s jelly products are able to successfully perform the same function for each of our clients as they did in the original donor.

FDA Literature and Examples

FDA Example – Pg. 16; IV

FDA Example – Pg. 20; 20

Positive correlation between the quantity of Wharton’s jelly in the umbilical cord and birth weight

Biomechanical properties of the human umbilical cord

Definitions

“The HCT/P is not combined with another article (with some limited exceptions); and – The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function.”

Regenative’s Difference

Our Wharton’s jelly products are not combined with any article except for saline and approved cryopreservative, which are both permitted under the FDA’s approved exemptions list.

Objective Evidence

“The manufacture of the HCT/P does not involve the combination of the cells or tissues with another article, except for water, crystalloids, or a sterilizing, preserving, or storage agent, provided that the addition of water, crystalloids, or the sterilizing, preserving, or storage agent does not raise new clinical safety concerns with respect to the HCT/P.”

FDA Literature and Examples

FDA Example – Pg. 3; 3

Definitions

“i. The HCT/P does not have a systemic effect and is not dependent upon the metabolic activity of living cells for its primary function; or
ii. The HCT/P has a systemic effect or is dependent upon the metabolic activity of living cells for its primary function, and;

  • a) Is for autologous use;
  • b) Is for allogeneic use in a first-degree or second-degree blood relative; or
  • c) Is for reproductive use.”

Regenative’s Difference

Regenative Labs’ Wharton’s jelly allografts rely on retaining the structural properties and function of the donor tissue. Its primary function in the donor is to cushion and protect the umbilical cord from mechanical stress. Our products are administered locally, directly to the site of a defect, and do not have an effect on the systems of the body.

Objective Evidence

Birth tissues are known for their immune-privileged properties and are never to be administered into the bloodstream. As viable structural tissues, our products may contain cells, however, the primary function of our products does not relate to their viability or any metabolic activity.

FDA Literature and Examples

FDA Example – Pg. 8; 3

Definitions

“An HCT/P may perform the same basic function or functions even when it is not used in the same anatomic location where it existed in the donor. A transplanted HCT/P could replace missing tissue, or repair, reconstruct, or supplement tissue that is missing or damaged, either when placed in the same or different anatomic location, as long as it performs the same basic function(s) in the recipient as in the donor.”

Regenative’s Difference

There are many anatomic locations where structural connective tissue exists throughout the body. The physician must consider homologous use relating to structural function as an inclusion/exclusion criterion before making a determination on whether to use our product(s) in any given case. When a structural tissue defect is defined and tissue augmentation is needed, it is then appropriate to administer our product with respect to homologous use.

Objective Evidence

Regenative Labs has collected retrospective data on the use of our product relating to structural defects located in many different anatomical locations throughout the body. The FDA clearly states that the homologous use of HCT/Ps depends on the basic function(s) of the tissue, and not on its anatomic location.

FDA Literature and Examples

FDA Example – Pg. 21; 21

Note:

Regenative Labs has gone to great lengths to ensure that we meet these criteria and we strongly recommend that all our providers follow this guidance as it relates to their own marketing and use of our products.

All of our labeling, advertising, and marketing content has passed strict compliance reviews by legal professionals. If you would like a free review of your site by one of our tissue bank auditors please click here.

 

Timeline

Here is a compilation of relevant FDA tissue bank regulations in chronological order dating back to 1993. This list may not be exhaustive*.

July 2020

Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use

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November 2017

Same Surgical Procedure Exception under 21 CFR 1271.15(b): Q&A Regarding the Scope of the Exception

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September 2017

Deviation Reporting for Human Cells, Tissues, and Cellular and Tissue-Based Products Regulated Solely Under Section 361 of the Public Health Service Act and 21 CFR Part 1271

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November 2016

Revised Recommendations for Determining Eligibility of Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products Who Have Received Human-Derived Clotting Factor Concentrates

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March 2016

Investigating and Reporting Adverse Reactions Related to Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Regulated Solely under Section 361 of the Public Health Service Act and 21 CFR Part 1271

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September 2015

Use of Donor Screening Tests to Test Donors of Human Cells, Tissues and Cellular and Tissue-Based Products for Infection with Treponema pallidum (Syphilis)

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December 2011

Current Good Tissue Practice (CGTP) and Additional Requirement for Manufacturers of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

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April 2008

Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered from Donors Who Were Tested for Communicable Diseases Using Pooled Specimens or Diagnostic Tests

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August 2007

Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products

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Regulation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) – Small Entity Compliance Guide

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September 2006

Compliance with 21 CFR Part 1271.150(c)(1) – Manufacturing Arrangements

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November 2004

Recommendations for Obtaining a Labeling Claim for Communicable Disease Donor Screening Tests Using Cadaveric Blood Specimens from Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)

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March 2002

Validation of Procedures for Processing of Human Tissues Intended for Transplantation

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January 2001

Human Cell, Tissue, and Cellular and Tissue-Based Products; Establishment Registration and Listing

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July 1997

Federal Register – Human Tissue Intended for Transplantation

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April 1996

Regulatory Information

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December 1993

Preliminary Rule

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