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Humanitarian Device Exemptions

A Humanitarian Device Exemption lets a company sell a device for a condition that affects fewer than 8,000 people a year in the US without proving it works the way a normal approval requires; it has to be safe and probably helpful. FDA has granted fewer than a hundred.

All 82 Humanitarian Device Exemptions FDA has approved since 1997: devices for conditions affecting under 8,000 people a year in the US, approved on probable benefit rather than proof of effectiveness.

  • HDEs approved: 82
  • In the last 10 years: 22
  • Median review, last 10 years: 14 months
  • Newest: OncoSil, Aug 14, 2026

HDEs per Year

Original approvals, by decision date.

How to read this

A hatched bar is a year that is not over, so its count covers only part of the year.

  • Full year
  • 2026 to date

By Review Panel

FDA's advisory panel for the device.

  • Neurology15
  • Orthopedic14
  • Cardiovascular14
  • Gastroenterology13
  • General & Plastic Surgery5
  • Hematology4
  • Anesthesiology4
  • Obstetrics/Gynecology4
  • Radiology2
  • Pathology2

Every HDE

Newest first. Review is from FDA receiving the application to its decision.
Aug 14, 2026OncoSilp-32 microparticle for distal cholangiocarcinoma intratumoral injectionOncoSil Medical USA, Inc.72 moRadiologySIYH200002
Mar 30, 2026River Stent Systemintracranial neurovascular stentSerenity Medical, Inc.34 moNeurologyNJEH230002
Dec 31, 2025PHIL Liquid Embolic Systemdural arteriovenous fistula liquid embolicMicroVention, Inc.14 moNeurologySGFH240004
Dec 27, 20244WEB Medical Talar Replacement Deviceprosthesis, total talus replacement, metalStryker11 moOrthopedicQNNH240001
Dec 4, 2024AMDS Hybrid Prosthesishybrid stent graft, thoracic aortic lesion treatmentArtivion, Inc.16 moCardiovascularQSKH230007
Apr 25, 2024nAbCyte Anti-AAVRh74var HB-FE Assayassays to detect pre-existing antibodies to adeno-associated virus (aav) viral vectorsLabcorp Drug Development9 moHematologyQWQH230005
Feb 21, 2024Selective Cytopheretic Device (SCD-PED)pediatric extracorporeal synthetic semipermeable membrane cartridge for acute kidney injurySeaStar Medical19 moHematologyQZVBH220740
Nov 17, 2023restor3d Total Talus Replacementprosthesis, total talus replacement, metalRestor3D, Inc.6 moOrthopedicQNNH230003
Sep 26, 2023TheraBionic P1stimulator, electric field, intrabuccalTherabionic, Inc.13 moGeneral & Plastic SurgeryQOMH220001
May 15, 2023REFLECT Scoliosis Correction Systemvertebral body tethering systemGlobus Medical, Inc.21 moOrthopedicQHPH210002
Sep 9, 2022NeVa VStemporary percutaneous transluminal cerebral artery dilatation deviceVesalio12 moNeurologyQTKH210004
Feb 17, 2021Patient Specific Talus Spacerprosthesis, total talus replacement, metalParagon 28, Inc.8 moOrthopedicQNNH200001
Dec 1, 2020Plasma Delipidation System (PDS-2 System)plasma processing system for converting alpha to pre-beta high-density lipoproteinHdl Therapeutics, Inc.23 moGastroenterologyQNBH190001
Nov 27, 2020Sonalleve MR-HIFUablation system, high intensity focused ultrasound (hifu), mr guided, orthopedicProfound Medical, Inc.20 moOrthopedicQNDH190003
Aug 23, 2019Minimally Invasive Deformity Correction (MID-C) Systemposterior ratcheting rod systemApifix , Ltd.29 moOrthopedicQGPH170001
Aug 16, 2019The Tether - Vertebral Body Tethering Systemvertebral body tethering systemZimmer Biomet Spine, Inc.2 moOrthopedicQHPH190005
May 23, 2019Optune Luaelectrical tumor treatment fieldsNovocure, GmbH7 moAnesthesiologyQGZH180002
Sep 14, 2018PK Papyrus Covered Coronary Stent Systemcoronary covered stentBiotronik AG12 moCardiovascularNIVH170004
Mar 20, 2018LIPOSORBER LA-15 Systemapheresis for focal glomerulosclerosis in adult and pediatric patientsKaneka Pharma America, LLC9 moGastroenterologyPBNH170002
Jun 19, 2017PulseRider Aneurysm Neck Reconstruction Deviceintracranial neurovascular stentMedos International SARL12 moNeurologyNJEH160002
May 12, 2017Flourish Pediatric Esophageal Atresia Anastomosis Devicepediatric esophageal atresia anastomosis deviceWilson-Cook Medical, Inc.17 moGastroenterologyPTKH150003
Jan 10, 2017THE AMPLATZER POST INFARCT MUSCULAR VSD OCCLUDERtranscatheter septal occluderABBOTT MEDICAL115 moCardiovascularMLVH070005
Dec 18, 2015FENIX CONTINENCE RESTORATION SYSTEMmechanical compression device fecal incontinence (non-manually operated)Torax Medical, Inc.25 moGastroenterologyPMHH130006
Dec 18, 2015PDGFRB FISH ASSAYfluorescence in situ hybridization, platelet-derived growth factor receptor, beta polypeptide (pdgfrb), rearrangementArup Labaratories13 moPathologyPMIH140005
Dec 18, 2015KIT D816V ASSAYkit d816v mutation detection systemArup Labaratories13 moPathologySGDH140006
Jul 16, 2015OPRAosseoanchored prostheses for the rehabilitation of transfemoral amputeesIntegrum AB81 moOrthopedicPJYH080004
Mar 5, 2015KANEKA LIXELLE BETA 2-MICROGLOBULIN APHERESIS COLUMNbeta 2-microglobulin apheresis columnKaneka Pharma America, LLC25 moGastroenterologyPDIH130001
Jan 23, 2015IMPELLA RP SYSTEMright ventricular bypass (assist) deviceAbiomed, Inc.4 moCardiovascularOJEH140001
Dec 12, 2014BAROSTIM NEO LEGACY IMPLANTABLE PULSE GENERATOR (IPG), PROGRAMMER SYSTEM,CAROTID SINUS LEAD (CSL) REPAIR KIT,EXTERNAL INstimulator, carotid sinus nerveCvrx, Inc.12 moCardiovascularDSRH130007
Aug 26, 2014PLEXIMMUNE ASSAYtest, cell mediated immune response, liver and small bowel transplant/transplantationPlexision, Inc.12 moClinical ChemistryPHKH130004
Aug 12, 2014XPS WITH STEEN SOLUTION PERFUSATEnormothermic preservation system for transplantation of initially unacceptable donor lungsXvivo Perfusion25 moGastroenterologyPHOH120003
Jul 25, 2014LVIS INTRALUMINAL SUPPORT DEVICEintracranial neurovascular stentMicroVention, Inc.9 moNeurologyNJEH130005
Jan 23, 2014CliniMACS CD34 Reagent Systemmagnetic cell selection system for cd34+ cells from hpc-apheresis used in treatment of acute myeloid leukemia (aml)Miltenyi Biotec, Inc.33 moHematologyOVGBH110018
Oct 10, 2013LIPOSORBER LA-15 SYSTEMapheresis for focal glomerulosclerosis in adult and pediatric patientsKaneka Pharma America, LLC13 moGastroenterologyPBNH120005
Feb 13, 2013ARGUS II RETINAL PROSTHESIS SYSTEMprosthesis, retinalCortigent, Inc.21 moOphthalmicNBFH110002
Dec 16, 2011EXCOR PEDIATRIC VENTRICULAR ASSIST DEVICEpediatric ventricular assist deviceBerlin Heart, Inc.18 moCardiovascularPCKH100004
Nov 18, 2011BSD-2000 HYPERTHERMIA SYSTEMrf/microwave hyperthermia system, cancer treatmentPyrexar Medical, Inc.30 moObstetrics/GynecologyPASH090002
Sep 28, 2011NEURX DIAPHRAGM PACING SYSTEM (DPS)diaphragmatic/phrenic nerve laparoscopically-implanted stimulatorSynapse Biomedical12 moAnesthesiologyOIRH100006
Apr 1, 2011CPAX ANEURYSM TREATMENT SYSTEMpolymeric neurovascular embolizationNeurovasx11 moNeurologyOUUH100002
Mar 10, 2011ELANA ARTERIOTOMY SYSTEMsurgical kitElana, Inc.27 moNeurologyPAXH080005
Jan 25, 2010MELODY TRANSCATHETER PULMONARY VALVE AND ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEMpulmonary valve prosthesis percutaneously deliveredMedtronic, Inc.17 moCardiovascularNPVH080002
Feb 10, 2009MEDTRONIC (ACTIVA)DEEP BRAIN STIMULATION FOR OCD THERAPYdeep brain stimulator for obsessive compulsive disorder (ocd)Medtronic Inc.,Neurological Division.39 moNeurologyOLMH050003
Oct 24, 2008IBV VALVE SYSTEMone-way air-leak valveGyrus Acmi, Inc.31 moAnesthesiologyOAZH060002
Oct 10, 2008INFUSE/MASTERGRAFT CERAMIC OR INFUSE HDE KITfiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hdeMedtronic Sofamor Danek, Inc.51 moOrthopedicOJZH040004
Oct 7, 2008CENTRIMAG RIGHT VENTRICULAR ASSIST SYSTEM (RVAS)right ventricular bypass (assist) deviceAbbott17 moCardiovascularOJEH070004
Jun 17, 2008NEURX RA/4 DEVICEdiaphragmatic/phrenic nerve laparoscopically-implanted stimulatorSynapse Biomedical15 moAnesthesiologyOIRH070003
Oct 25, 2007EpiceloceVericel Corporation105 moGeneral & Plastic SurgeryOCEBH990200
Oct 25, 2007EPICEL (CULTURED EPIDERMAL AUTOGRAFTS)cultured epithelial autograftGenzyme Corp.105 moGeneral & Plastic SurgeryOCEH990002
May 8, 2007ENTERPRISE VASCULAR RECONSTRUCTIVE DEVICE AND DELIVERY SYSTEMintracranial neurovascular stentMedos International SARL15 moNeurologyNJEH060001
Apr 11, 2007ONYX ANEURYSM SYSTEM, ONYX HD-500 MODEL 105-8101-500polymerizing, neurovascular embolization materialEv3, Inc.13 moNeurologyOBAH060003
Jan 24, 2007MESOMARKcancer monitoring test system, soluble mesothelin-related peptides, epithelioid/biphasic mesotheliomaFujirebio Diagnostics,Inc.4 moImmunologyOAWH060004
Sep 5, 2006ABIOCOR IMPLANTABLE REPLACEMENT HEARTartificial heartAbiomed, Inc.24 moCardiovascularLOZH040006
Mar 31, 2006FETOSCOPY INSTRUMENT SETamnioscope, transabdominal (fetoscope) (and accessories)KARL STORZ Endoscopy-America, Inc.21 moObstetrics/GynecologyHFAH040005
Aug 3, 2005WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETERintracranial neurovascular stentStryker Corp.6 moNeurologyNJEH050001
Mar 30, 2005COAXIA NEUROFLO CATHETERcatheter, neuro-vasculature, occluding balloonZoll Circulation19 moNeurologyPAVH030005
Jul 26, 2004INTACS PRESCRIPTION INSERTS FOR KERATOCONUSimplant, corneal, refractiveAddition Technology5 moOphthalmicLQEH040002
Apr 7, 2004OP-1 PUTTY FOR POSTEROLATERAL SPINAL FUSIONSfiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hdeOlympus Biotech Corporation15 moOrthopedicOJZH020008
Feb 25, 2004DEBAKEY VAD CHILD VENTRICULAR ASSIST DEVICE SYSTEMventricular (assist) bypassReliantheart, Inc.7 moCardiovascularDSQH030003
Feb 24, 2004HEARTSBREATHtest, volatile organic compounds breath analysisMenssana Research, Inc.6 moClinical ChemistryPARH030004
Nov 21, 2003CONTEGRA PULMONARY VALVED CONDUITpulmonic valved conduitMedtronic, Inc.18 moCardiovascularMWHH020003
Apr 15, 2003MEDTRONIC ACTIVA DEEP BRAIN STIMULATION (DBS)SYSTEMimplanted subcortical electrical stimulator (motor disorders)Medtronic Neuromodulation5 moNeurologyMRUH020007
Sep 11, 2002NEUROFORM MICRODELIVERY STENTintracranial neurovascular stentStryker Neurovascular5 moNeurologyNJEH020002
Aug 9, 2002NEUROLINK SYSTEMintracranial neurovascular stentAbbott Vascular-Cardiac Therapies9 moNeurologyNJEH010004
Mar 22, 2002ASCENSION PIPhigh demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesisSmith & Nephew, Inc.3 moOrthopedicOMXH010005
Oct 17, 2001OP-1 IMPLANTfiller, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction - hde, long bone nonunionOlympus Biotech Corporation5 moOrthopedicOKDH010002
Aug 28, 2001METACARPAL PHALANGEAL JOINT IMPLANTsemi-constrained metal/polymer finger joint prosthesisEncore Medical L/P. D/B/A Djo Surgical3 moOrthopedicMPKH010001
Feb 21, 2001OrcelpbdOrtec International, Inc.15 moGeneral & Plastic SurgeryPBDBH991300
Feb 21, 2001COMPOSITE CULTURED SKINcomposite cultured skinOrtec Intl., Inc.15 moGeneral & Plastic SurgeryPBDH990013
Jan 10, 2001JOMED JOSTENT CORONARY STENT GRAFTcoronary covered stentAbbott Vascular Devices11 moCardiovascularNIVH000001
May 11, 2000TAS ECT TESTecarin clotting timeCardiovascular Diagnostics, Inc.6 moHematologyPBAH990012
Mar 31, 2000GASTRIC ELECTRICAL STIMULATION (GES) SYSTEMintestinal stimulatorEnterra Medical, Inc.4 moGastroenterologyLNQH990014
Dec 10, 1999MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERESmicrospheres radionuclideBoston Scientific Corporation16 moRadiologyNAWH980006
Sep 30, 1999SHELHIGH NO-REACT PORCINE PULMONIC VALVE CONDUITpulmonic replacement heart valveShelhigh, Inc.11 moCardiovascularPALH980007
Sep 20, 1999ARTIFICIAL BOWEL SPHINCTER PROSTHESISimplanted fecal incontinence deviceAmerican Medical Systems, Inc.6 moGastroenterologyMIPH990003
Feb 19, 1999NEUROCONTROL VOCARE BLADDER SYSTEMelectrical stimulation bladder systemMdci Medical Device Consultants, Inc.2 moGastroenterologyPAZH980008
Dec 28, 1998NEUROCONTROL CORPORATION VOCARE BLADDER SYSTEMbladder systemMdci5 moGastroenterologyPATH980005
Sep 28, 1998PROXIMAL INTERPHALANGEAL (PIP) FINGER JOINTsemi-constrained metal/polymer finger joint prosthesisEncore Medical L/P. D/B/A Djo Surgical6 moOrthopedicMPKH980002
Apr 30, 1998PERMA-FLOW CORONARY GRAFT MODEL 2C10graft, bypass, coronary arteryPossis Medical, Inc.6 moCardiovascularNAVH970005
Apr 6, 1998IMMUNOSORBA PROTEIN A COLUMN AND IMMUNOSORBA PROTEIN A SEPHAROSE COLUMNcolumns, immunoadsorption in extracorporeal systemsFresenius Medical Care5 moGastroenterologyLQQH970004
Dec 16, 1997URO-STIM THERAPEUTIC STIMULATION UNITstimulator, bladderWilliam E. Kaplan, M.D.3 moGastroenterologyNAZH970003
Sep 30, 1997KCH FETAL BLADDER DRAINAGE CATHETERstent, bladder, fetalRocket Medical Plc5 moObstetrics/GynecologyMPRH970001
Feb 14, 1997HARRISON FETAL BLADDER STENT SETstent, bladder, fetalCook Incorporated3 moObstetrics/GynecologyMPRH960001

Original HDEs only; supplements are left out. An HDE device must show it is safe and its probable benefit outweighs the risk, and most can only be used where an institutional review board has approved it. Refreshed weekly. FDA CDRH, Humanitarian Device Exemption database

Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.