Legislative Committee 

Shan Zozula,  BS, TS(ABB)

The Legislative Committee has been busy tracking developments related to FDA activities. First, the FDA’s deeper understanding of the importance of embryo donation has resulted in a proposed rule (FDA-2014-N-1484), “Revision to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products”, to amend some of its current regulations and guidances. Click here to read the proposed rule on the FDA website. All comments are to be submitted by March 31, 2015. CRB sees this as a step in the right direction for the FDA’s 21 CFR Part 1271, but encourages all to review the document and comment if needed. Some of the proposed amendments may require a modification to your current SOPs for embryo adoption.

An additional draft guidance attempts to clarify the 2006 guidance entitled “Guidance for Industry and FDA Staff: Minimal Manipulation of Structural Tissue Jurisdictional Update”. The guidance (available here) provides answers to some questions, by providing examples, which were generated by the earlier 2006 guidance. We would also encourage you to review and comment as needed.

All electronic comments are to be submitted to http://www.regulations.gov. All written comments can be submitted to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
The FDA has also provided notice of new guidances they plan to publish in 2015, including

• Draft Guidance for Industry: Homologous Use of Human Cells, Tissues, and Cellular and Tissue Based Products
• Draft Guidance for Industry: Manufacturer Investigation of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Adverse Reactions

While these have yet to be published, it will be important to look for them later this year.

Lastly, CRB has been carefully monitoring the activity of several organizations, including AAB/NILA as they tackle the proposed FDA rules on Laboratory Developed Tests (LDT). To review those comments, please follow this link. It is reasonable to expect that actions taken by the FDA on LDTs will impact ART. Prudence dictates we are all up to speed on this regulation.

If there are any additional legislative concerns, both federal and local, please contact CRB at crb-aab@aab.com and we will look into it.

Shane Zozula, BS, TS(ABB)
Chair, CRB LegCom