The FDA released an official response to AATB's Citizen Petition. In its response, the FDA confirms that human acellular dermal matrix (hADM) allografts that otherwise meet the requirement for regulation solely under Section 361 of the PHSA shall not be considered non-homologous or otherwise ineligible for classification as "361 HCT/Ps" solely because they are labeled and/or marketed for use in post-mastectomy breast reconstruction.
In December 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". Given the lack of response to the Citizen Petition, in April 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 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, the FDA announced and enforced a new rule, stating that hADMs intended for breast reconstruction surgery were a Class III medical device because it is a non-homologous use.
This is a significant victory for individuals, primarily women, facing a breast cancer diagnosis. For almost two decades, surgeons have used hADMs in post-mastectomy breast reconstruction, treating many thousands of individuals with excellent results and a return to normality not formerly possible. The use of hADM allografts in post-mastectomy breast reconstruction has been so successful that it has become the standard of care.