Center for Devices and Radiological Health Device Exemptions

$79 / year

the Center for Devices and Radiological Health (CDRH) Humanitarian Device Exemptions dataset includes the list of Humanitarian Device Exemptions delivered by the FDA. An 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. A device manufacturer`s research and development costs could exceed its market returns for diseases or conditions affecting small patient populations.

Complexity

The 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.

An Humanitarian Use Device (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

2018-03-22

Version

2018-03-22

Update Frequency

Irregular

Temporal Coverage

1997-02 to 2018-03

Spatial Coverage

United States

Source

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

Source License URL

John Snow Labs Standard License

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

Other Titles

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

Name Description Type Constraints
HDE_Number_ApprovalHumanitarian Device Exemptions Number Approvalstringrequired : 1 maxLength : 8
Approval_DateHumanitarian Device Exemptions Approval Datedaterequired : 1
Docket_NumberDevice Docket Numberstring-
Device_NameHumanitarian Device Namestringrequired : 1
Company_Name_and_AddressCompany Name and Addressstringrequired : 1
Device_Description_and_Device_IndicationsDevice Description and/or Device Indicationsstringrequired : 1
HDE_Number_ApprovalApproval_DateDocket_NumberDevice_NameCompany_Name_and_AddressDevice_Description_and_Device_Indications
H9900082000-09-0300M-1228Telescopic Plate Spacer (TPS) Spinal SystemInterpore Cross InternationalThe sponsor has withdrawn this HDE effective Sept. 1, 2010
H0400042008-10-1008M-0562INFUSE/MASTERGRAFT Posterolateral Revision DeviceMedtronic Sofamor Danek USA, Inc.This device has been withdrawn at the request of the sponsor effective March 23, 2010.
H9900071999-07-1299M-5327BioGlueSurgical AdhesiveCryoLife, Inc.For use as an adjunct in the surgical repair of acute thoracic aortic dissections. NOTE: This HDE is superseded by PMA P010003.
H9700031997-12-1698M-0163UrostimWilliam E. Kaplan, M.D. and Ingrid Richards, R.N., MSN Chicago, IL 60614For use in children for the treatment of neurogenic bladder disease secondary to spina bifida
H0200042003-07-0703M-0305DermagraftSmith and Nephew Wound ManagementThis device has been withdrawn by the sponsor as of September 28, 2007. Jurisdiction for this product has been transferred to CBER.
H0100022001-10-1701M-0482OP-1 ImplantStryker Biotech Hopkinton, MAThe device is indicated for use as an alternative to autograph in recalcitrant long bone nonunions where use of autograph is unfeasible and alternative treatments have failed.
H9900031999-09-2099M-4619ActiconNeosphincterAmerican Medical Systems, Inc.For the treatment of severe fecal incontinence in post-pubescent males and females who have failed, or are not candidates for, less invasive forms of restorative therapy.
H9700011997-09-3098M-0164King's College Hospital (KCH) Fetal Bladder Drainage CatheterRocket Medical PLC EnglandFor urinary tract decompression following the diagnosis of post-vesicular obstructive uropathy in fetuses 18 to 32 weeks gestational age
H0700042008-10-0708M-0563Levitronix Centrimag Right Ventricular Assist System (RVAS)Levitronix, LLCThis device is indicated for temporary circulatory support for up to 14 days for patients in cardiogenic shock due to acute right ventricular failure.
H0000012001-10-01010M-006JOMED JOSTENT Coronary Stent GraftJOMED ABFor Use in the treatment of free perforations, defined as free contrast extravasation into the pericardium, in native coronary vessels or saphenous vein bypass grafts > 2.75 mm in diameter.