Center for Devices and Radiological Health Device Exemptions

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The Center for Devices and Radiological Health (CDRH) Humanitarian Device Exemptions dataset includes the list of Humanitarian Device Exemptions delivered by the Food and Drug Administration (FDA). A 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.

Complexity

The Humanitarian Use Device (HUD) provision of the regulation provides an incentive for the development of devices for use in the treatment or diagnosis of diseases affecting these populations. The regulation provides for the submission of a humanitarian device exemption (HDE) application, which is similar in both form and content to a premarket approval (PMA) application but is exempt from the effectiveness requirements of a PMA.

A HUD application is not required to contain the results of scientifically valid clinical investigations demonstrating that the device is effective for its intended purpose. The application, however, must contain sufficient information for FDA to determine that the device does not pose an unreasonable or significant risk of illness or injury, and that the probable benefit 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. Additionally, the applicant must demonstrate that no comparable devices are available to treat or diagnose the disease or condition and that they could not otherwise bring the device to market.

Date Created

2011

Last Modified

2019-09-13

Version

2019-09-13

Update Frequency

Irregular

Temporal Coverage

1997-02 to 2018-09

Spatial Coverage

United States

Source

John Snow Labs; U.S. Food and Drug Administration (FDA);

Source License URL

Source License Requirements

N/A

Source Citation

N/A

Keywords

Humanitarian Device, CDRH, CDRH Device Exemptions, FDA Devices, Humanitarian Devices, Humanitarian Use Devices, HUD Regulations, Medical Device

Other Titles

FDA Humanitarian Device Exemptions, FDA Center for Devices and Radiological Health

NameDescriptionTypeConstraints
HDE_Number_ApprovalHumanitarian Device Exemptions Number Approvalstringrequired : 1
Approval_DateHumanitarian Device Exemptions Approval Datedaterequired : 1
Docket_NumberDevice Docket Numberstring-
Device_NameHumanitarian Device Namestringrequired : 1
Company_NameCompany namestringrequired : 1
Office_LocationCompany addressstring-
Device_Description_and_Device_IndicationsDevice Description and/or Device Indicationsstringrequired : 1
HDE Number ApprovalApproval DateDocket NumberDevice NameCompany NameOffice LocationDevice Description and Device Indications
H1700042018-09-14PK Papyrus Covered Coronary Stent SystemBiotronik, IncApproval for the PK Papyrus Covered Coronary Stent System. This device is indicated for the treatment of acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter.
H1700022018-03-2075-DayLIPOSORBER® LA-15 SystemKaneka Pharma America LLCVienna, VA22180Approval for the LIPOSORBER® LA-15 System to expand the indication to include adult patients with nephrotic syndrome. The LIPOSORBER® LA-15 is indicated for use in the treatment of adult and pediatric patients with nephrotic syndrome associated with primary focal segmental glomerulosclerosis, when standard treatment options, including corticosteroid and/or calcineurin inhibitors treatments, are unsuccessful or not well tolerated and the patient has a GFR 60 ml/min/1.73m2 or the patient is post renal transplantation.
H1600022017-06-19PulseRider Aneurysm Neck Reconstruction DevicePulsar Vascular, IncLos Gatos, CA 95032Approval for the PulseRider Aneurysm Neck Reconstruction Device. This device is indicated for use with neurovascular embolic coils in patients 18 years of age for the treatment of unruptured wide-necked intracranial aneurysms with neck widths 4 mm or dome to neck ratio < 2 originating on or near a vessel bifurcation of the basilar tip or carotid terminus with at least a portion of the aneurysm neck overlapping the lumen of the parent artery. The inflow vessels should have diameters from 2.7 mm to 4.5 mm.
H1500032017-05-1275-DayPediatric Esophageal Atresia DeviceWilson-Cook Medical IncWinston-Salem, NC 27105Approval for the Pediatric Esophageal Atresia Device. The Flourish Pediatric Esophageal Atresia Device is indicated for use in lengthening atretic esophageal ends and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. This device is indicated for atretic segments 4cm apart.
H0700052017-01-10AMPLATZER Post-Infarct Muscular VSD OccluderAGA Medical Corporation5050 Nathan Lane North Plymouth, MN 55442Approval for the AMPLATZER Post-Infarct Muscular VSD Occluder. The AMPLATZER Post-Infarct Muscular VSD Occluder is a percutaneous transcatheter occlusion device intended for closure of post myocardial infarct muscular ventricular septal defects in patients who are not satisfactory surgical candidates.
H1300062015-12-18FENIX Continence Restoration SystemTorax Medical, IncShoreview, MN 55126Approval for the FENIX Continence Restoration System. This device is indicated for the treatment of fecal incontinence in patients who are not candidates for or have previously failed conservative treatment and less invasive therapy options (e.g. bulking agents, radiofrequency ablation, sacral nerve stimulation).
H1400052015-12-18PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome / Myeloproliferative Disease (MDS / MPD)ARUP LaboratoriesSalt Lake City, UT84108Approval for the PDGFRB FISH for Gleevec Eligibility in Myelodysplastic Syndrome/Myeloproliferative Disease (MDS/MPD). This device is indicated for the qualitative detection of PDGFRB gene rearrangement from fresh bone marrow samples of patients with MDS/MPD with a high index of suspicion based on karyotyping showing a 5q31~33 anomaly. The PDGFRB FISH assay is indicated as an aid in the selection of MDS/MPD patients for whom Gleevec (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.
H1400062015-12-18KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM)ARUP LaboratoriesSalt Lake City, UT 84108Approval for the KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM). KIT D816V Mutation Detection by PCR for Gleevec Eligibility in Aggressive Systemic Mastocytosis (ASM) (referred to as the "KIT D816V assay") is an in vitro diagnostic test intended for qualitative polymerase chain reaction (PCR) detection of KIT D816V mutational status from fresh bone marrow samples of patients with aggressive systemic mastocytosis. The KIT D816V mutational assay is indicated as an aid in the selection of ASM patients for whom Gleevec (imatinib mesylate) treatment is being considered. This assay is for professional use only and is to be performed at a single laboratory site.
H0800042015-07-162015-M-2584Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) DeviceIntegrum ABAlexandria, Virginia 22314Approval for the Osseoanchored Prostheses for the Rehabilitation of Amputees (OPRA) Device. The OPRA device is indicated for patients who have transfemoral amputation due to trauma or cancer and who have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA device is intended for skeletally mature patients. The patient failed to receive benefit from a socket prostheses due to problems such as: -Recurrent skin infections and ulcerations in the socket contact area -Pain -A short stump preventing the use of socket prosthesis -Volume fluctuation in the stump -Soft tissue scarring -Extensive area of skin grafting -Socket retention problems due to excessive perspiration -Restricted mobility
H1300012015-05-03Kaneka Lixelle 2-microglobulin Apheresis ColumnKaneka Pharma America, LLCNew York, NY 10036Approval for the Lixelle 2-microglobulin Apheresis Column (also called the Beta2-Microglobulin Apheresis Column or 2M). This device is indicated for the treatment of patients with clinically diagnosed dialysis-related amyloidosis (DRA).