FDA & Dilators Update from APTA | March 2024

Academy News, Practice & Advocacy,
Thank you to all of our members who have contacted the APTA and the Academy to seek clarification on the evolving FDA and dilators issue. We are providing a brief update below as APTA National continues to investigate.

APTA National is currently investigating a new enforcement decision handed down by the FDA that could have significant implications for the PT profession as a whole. Multiple members have brought it to our attention that FDA notified Intimate Rose, the largest supplier of pelvic health DME, that their dilators are Class 2 medical devices. This means that Intimate Rose must receive a prescription in order to supply these dilators to the PTs seeking to purchase them.

APTA staff and a representative from the Academy spoke with Intimate Rose leadership and learned that FDA informed them that this change marks an end to FDA’s non-enforcement of requirements for Class 2 devices registered with FDA. This development is deeply concerning and is why APTA is looking into this matter. This decision by FDA has the potential to dramatically impact PTs’ access to medical devices once widely available through Intimate Rose and other online retailers. This enforcement is currently limited to devices registered with FDA. However, due to the potentially broad impact of this decision, we are currently gathering more information on FDA’s actions to better understand their reasoning.

Due to the impact on our members, and the profession-wide implications, APTA is taking this issue very seriously and will continue to investigate.