AATB Requests Meeting with FDA to Discuss Potential Litigation 

April 12, 2022

AATB's legal counsel sent an email to the FDA Office of Chief Counsel requesting a meeting to discuss potential litigation against the FDA regarding its reclassification of human acellular dermal matrix (hADM) allografts for post-mastectomy breast reconstruction.

For nearly two decades, FDA has regulated hADMs solely as HCT/Ps under section 361 of the Public Health Service Act and Part 1271 of title 21 of the CFR. Recently, however, FDA announced and enforced a new rule, stating that hADMs intended for use in breast reconstruction surgery are a Class III medical device because it is a non-homologous use.

AATB is dedicated to saving and improving lives by promoting the safety, quality, and availability of donated human tissue and is committed to supporting its members. The FDA reclassification of hADMs for post-mastectomy breast reconstruction has created a potentially detrimental situation for not only our members who process and distribute the grafts but also for women recovering from breast cancer. 

For over 14 years, surgeons have used hADMs in post-mastectomy breast reconstruction, treating many thousands of women with excellent results and a return to normality to a degree not formerly possible. The use of hADMs in post-mastectomy breast reconstruction has been so successful that it has become the standard of care across the country.

If hADMs are regulated as medical devices under PHS 361, FDCA, 21 CFR 1271, and the medical device regulations, to legally market them, it would require going through the medical device premarketing approval process which potentially requires clinical studies to prove safety and effectiveness. While this lengthy process is undertaken, there could potentially be a lack of access to hADMs for breast reconstruction.
In December of 2019, AATB submitted a Citizen Petition requesting that the FDA continue to regulate hADMs for breast reconstruction solely under PHS 361 and 21 CFR 1271, i.e., as “361 HCT/Ps”, to which the FDA failed to respond and has instead taken further steps to enforce its new position.

AATB is asking the FDA to cease enforcement of its position until they respond to the Citizen Petition filed more than two years ago. AATB does not come to litigation lightly, and it is our sincere hope that we can find a resolution without litigation. AATB will update its members as new information is available.