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Humanitarian Use Devices and Humanitarian Device Exemption

A Humanitarian Use Device (HUD) is a "medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year."  A Humanitarian Device Exemption (HDE) is an application that is similar to a premarket approval (PMA) application, but is exempt from the effectiveness requirements of the Food, Drug, and Cosmetic Act (FD&C Act).  FDA approval of an HDE authorizes an applicant to market a HUD subject to certain profit and use restrictions.  HUDs cannot be sold for profit, except in certain circumstances.

Under section 520(m)(6)(A)(i) of the FD&C Act, as amended by FDASIA, a HUD is only eligible to be sold for profit after receiving HDE approval if the device meets the following criteria:

1. The device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or

2. The device is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients or that occurs in  pediatric patients in such numbers that development of the device for such patients is impossible, highly impracticable, or unsafe.

If an HDE-approved device does not meet either of the eligibility criteria, the device cannot be sold for profit.

Pediatric Humanitarian Device Exemptions Approved to be Sold for Profit and Reviewed by the Pediatric Advisory Committee (PAC)

HDE Number
Approval Date and Docket Number
Device NameCompany Name and AddressDevice Description /
Device Indications
Epicel® (cultured epidermal autografts)Vericel Corporation
Cambridge, MA 02139
Epicel is an aseptically processed wound dressing composed of the patient’s own (autologous) keratinocytes grown ex vivo in the presence of proliferation-arrested, murine (mouse) fibroblasts. Epicel consists of sheets of proliferative, autologous keratinocytes, ranging from 2 to 8 cell layers thick and is referred to as a cultured epidermal autograft. Each graft of Epicel is attached to petrolatum gauze backing with titanium surgical clips and measures approximately 50 cm2 in area.

Epicel is indicated for use in adult and pediatric patients who have deep dermal or full thickness burns comprising a total body surface area (TBSA) greater than or equal to 30%. It may be used in conjunction with split-thickness autografts, or alone in patients for whom split-thickness autografts may not be an option due to the severity and extent of their burns.
Impella RP SystemABIOMED, Inc.
Danvers, MA 01923
Approval for the Impella RP System. This device is indicated for providing circulatory assistance for up to 14 days in pediatric or adult patients with a body surface area >=1.5 m2 who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.
Pleximmune™Plexision Inc
Pittsburg, PA V 15224
Approval for Pleximmune™. The Pleximmune™ test is intended to be performed at a single laboratory to measure the CD154 expression on T-cytotoxic Memory cells (TcM) in patient's peripheral blood lymphocytes (PBL) isolated from heparinized whole blood (anticoagulant – sodium heparin). The Pleximmune™ test is a qualitative prognostic test intended to be used in patients less than 21 years old with liver or small bowel transplantation. The Pleximmune™ test is an aid in the evaluation of the risk of acute cellular rejection (ACR) and must be used in conjunction with biopsy, standard clinical assessment and other laboratory information.
The Pleximmune™ test is intended for use at the following time periods:
  1. Pre-transplantation period: For blood samples collected before transplantation, the test predicts the risk of transplant rejection within 60 days after transplantation; and
  2. Early and late post-transplantation period: For blood samples collected within 60 days (early) after transplantation and for blood samples collected at 200 or more days (late) after transplantation, the test predicts the risk of transplant rejection within 60 days after sampling.
Kaneka Liposorber® LA-15 SystemKaneka Pharma America LLCApproval for the Kaneka Liposorber® LA-15 System. The device is indicated for use in the treatment of pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when: 1) Standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, are unsuccessful or not well tolerated and the patient has a GFR ≥ ml/min/1.73m2; or 2) The patient is post renal transplantation.
Berlin Heart EXCOR® Pediatric Ventricular Assist Device (VAD)Berlin Heart, Inc.The EXCOR is intended to provide mechanical circulatory support as a bridge to cardiac transplantation for pediatric patients. Pediatric candidates with severe isolated leftventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support may be treated using the EXCOR.
Elana Surgical KitHUDElana, Inc.The Elana Surgical KitHUD, when connected to the Spectranetics Xenon-Chloride Laser Model CVX-300, is indicated for creating arteriotomies during an intracranial vascular bypass procedure in patients 13 years of age or older with an aneurysm or a skull base tumor affecting a large (>2.5 mm), intracranial artery that failed balloon test occlusion, cannot be sacrificed, or cannot be treated with conventional means due to local anatomy or complexity.
CONTEGRA Pulmonary Valved ConduitMedtronic, IncThe CONTEGRA Pulmonary Valved Conduit is indicated for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in patients aged less than 18 years with any of the following congenital heart malformations:
  • Pulmonary Stenosis
  • Tetralogy of Fallot
  • Truncus Arteriosus
  • Transposition with Ventricular Septal Defect (VSD)
  • Pulmonary Atresia
In addition, the conduit is indicated for the replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits.
Medtronic Activa Dystonia TherapyMedtronic NeurologicalFor unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) to aid in the management of chronic, intractable (drug refractory) primary dystonia, including generalized and/or segmental dystonia, hemidystonia, and cervical dystonia (torticollis) in patients seven years of age or above
Enterra™ Therapy System (formerly named Gastric Electrical Stimulation (GES) SystemMedtronic, Inc.For the treatment of chronic, intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.


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