Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year.
The number of patients diagnosed with AML in first remission (CR1) and indicated for allogeneic transplantation enables the CliniMACS CD34 Reagent System to be regulated and approved as an HUD. The Humanitarian Device Exemption (HDE) regulatory pathway is similar in both format and content to a premarket approval (PMA) application, but it is exempt from the effectiveness requirements of a PMA. Given the low patient numbers involved, an HDE application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. Therefore, the effectiveness of the device for this use has not been demonstrated.
The approval as an HUD, however, asserts that there was sufficient information for the FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury. Furthermore, the clinical data supported the premise of a “probable benefit”; in that the risk to health outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. The CliniMACS CD34 Reagent System was shown to meet these requirements.
Information on the clinical study that supported the HDE approval of the CliniMACS CD34 Reagent System can be found in Clinical data.
As a user of an HUD you have certain obligations under the law. As the holder of the HDE for the CliniMACS CD34 Reagent System, Miltenyi Biotec is responsible for ensuring that the products are used under physician order and only in facilities having a properly constituted and functioning Institutional Review Board (IRB). If you are a treating physician within an institution where the CliniMACS CD34 Reagent System will be used, you are responsible for obtaining IRB approval for use of the CliniMACS CD34 System before patients are treated. (Please refer to your institution-specific investigator disclosure and/or IRB policies or contact your Miltenyi clinical applications manager for more information.)
Click here for the letter describing how Miltenyi will ascertain the IRB requirement per HDE regulations.
Authorized by U.S. Federal Law for use in the treatment of patients with acute myeloid leukemia (AML) in first complete remission. The effectiveness of the device for this use has not been demonstrated.
Indications for Use
The CliniMACS® CD34 Reagent System is indicated for processing hematopoietic progenitor cells collected by apheresis (HPC, Apheresis) from an allogeneic, HLA-identical, sibling donor to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional graft versus host disease (GVHD) prophylaxis in patients with acute myeloid leukemia (AML) in first morphologic complete remission.
Do not use CD34+ cells prepared with CliniMACS CD34 Reagent System in patients with known hypersensitivity to murine (mouse) proteins or iron dextran.