FDA Announces 2016 Public Hearing on Draft HCT/P Guidance Documents
In 2015, FDA issued four draft guidance documents on its interpretation of 21 C.F.R. Part 1271, the regulations pertaining to human cells, tissues, and cellular and tissue-based products (“HCT/Ps”). According to FDA, these draft guidance documents are intended to clarify FDA’s policies on applying the criteria of 21 C.F.R. 1271.10(a).
The criteria set forth in 21 C.F.R. 1271.10(a) are important because HCT/Ps that satisfy them are only regulated by Part 1271 and are not subject to FDA’s onerous and expensive pre-market approval processes. The four criteria are: (i) minimal manipulation, (ii) homologous use, (iii) not combined with another article (with some exceptions), and (iv)not having a systemic effect and not dependent upon the metabolic activity of living cells for primary function (with some exceptions).
The four draft guidance documents released by FDA this year are:
- Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products;
- Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) from Adipose Tissue: Regulatory Considerations;
- Same Surgical Procedure Exception under 21 CFR 1271.15(b): Questions and Answers Regarding the Scope of the Exception; and, most recently,
- Homologous Use of Human Cells, Tissues, and Cellular and Tissue-Based Products.
All four draft guidance documents can also be found on FDA’s website here. With the issuance of the Homologous Use draft guidance document in October FDA also announced that it will accept comments on all four draft guidance documents through April 29, 2016.
These draft guidance documents have been the subject of significant discussion and debate throughout the HCT/P industry. The draft Minimal Manipulation guidance document, in particular, has been the subject of industry criticism, with many in the industry stating the document creates more confusion than clarity. As a result, FDA has announced it will hold a public hearing on April 13, 2016 to discuss comments on the four draft guidance documents. The Federal Register announcement for the hearing can be found by clicking here. The announcement includes instructions for submitting comments and registering to speak at the hearing and specifies that FDA is looking for comments on the scope of the draft guidance documents, comments addressing the specific questions posed by each guidance document, and comments on the clarity and consistency of the draft guidance comments.
The public hearing is a prime opportunity for industry stakeholders to directly communicate with FDA and offer input into the agency’s HCT/P policy. This will likely be a well-attended gathering and all members of the public are encouraged to attend. Our life sciences attorneys will be in attendance with many of our clients and colleagues and we are always happy to answer questions about FDA’s HCT/P regulations and policies.
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