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FDA Releases Final Guidance Documents on Minimal Manipulation and Homologous Use and the Same Surgical Exception

Bulletin 17-13

November 17, 2017

On Thursday, November 16, the U.S. Food and Drug Administration (FDA) released two final guidance documents - one on minimal manipulation and homologous use, and one regarding the same surgical exception. The Regulatory Considerations for Human Cell, Tissues, and Cellular and Tissue- Based Products: Minimal Manipulation and Homologous Use is a guidance document intended to provide clarity on the determination of whether HCT/Ps are subject to FDA's premarket review requirements, while the Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception guidance document is intended to provide clarity as to whether an establishment may qualify for the "same surgical" exception under 21 CFR 1271.15(b).

The AATB provided extensive feedback and comments to the FDA in response to the previously released draft versions of these guidance documents. After reviewing the final guidance documents, it is clear that the FDA considered these comments and concurred with multiple recommendations that the AATB provided.

Here are some of our key advocacy wins:

  • The confusing and misunderstood new term "main function" is not present in either of the finalized guidance documents. This was one of the primary concerns AATB raised in our comments to FDA.
  • The FDA included AATB's recommendation that the processing steps which constitute minimal manipulation are not equivalent to those for the same surgical exception (i.e. agreed that the same surgical exception should involve a narrower list).
  • The FDA accepted the AATB recommended definitions of "original" and "relevant," which are important for determining homologous use.
  • At the request of the FDA, the AATB provided many examples of what should and should not be a 361 HCT/P. FDA used many of the examples that the AATB provided regarding what is and is not a 361.
  • The FDA provided clear definitions of repair, reconstruction, and replacement, which AATB had requested.
  • The FDA maintained two key processes for ascertaining whether a product is a 361 HCT/P - the Tissue Reference Group (TRG) and the Request for Designation (RFD) processes

You can read more about these documents in the FDA press release and a statement by Commissioner Gottlieb.

It is encouraging to see that the AATB's comments outlining our positions on these topics were helpful in shaping the FDA's final guidance documents, and we appreciate the Agency's willingness to work cooperatively throughout this process. We are also pleased that through the efforts of the AATB Tissue Policy Group (TPG) we have had this opportunity to advocate for our members and accredited banks, and we will continue to do so in the future.