Humanitarian Device Exemption

$79 / year

This 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.
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 HDE 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.

An approved HDE authorizes the marketing of the HUD. However, an HUD may only be used in facilities that have established a local institutional review board (IRB) to supervise clinical testing of devices and after an IRB has approved the use of the device to treat or diagnose the specific disease.

Date Created

2011

Last Modified

2018-03-20

Version

2018-03-20

Update Frequency

Irregular

Temporal Coverage

1997-02 to 2017-08

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

Other Titles

FDA Humanitarian Device Exemption, Humanitarian Device Exemption list

Name Description Type Constraints
Device_NameHumanitarian Device Namestringrequired : 1
CompanyHumanitarian Device Company Namestringrequired : 1
Approval_DateHumanitarian Device Exemptions Approval Datedaterequired : 1
HDE_Number_ApprovalHumanitarian Device Exemptions Number Approvalstringrequired : 1
Device_NameCompanyApproval_DateHDE_Number_Approval
OPRAINTEGRUM AB2015-07-16H080004
ABIOCORABIOMED INC.2006-11-08H040006/S001
ABIOCORABIOMED INC.2008-01-17H040006/S002
EpicelGenzyme Biosurgery2007-10-25BH990200/0
PLEXIMMUNE ASSAYPLEXISION INC.2014-08-26H130004
IMPELLA RP SYSTEMABIOMED INC.2015-01-23H140001
ENTERRA INSMEDTRONIC Inc.2011-06-17H990014/S058
ENTERRA INSMEDTRONIC Inc.2011-06-23H990014/S059
IBV VALVE SYSTEMSPIRATION INC.2008-10-24H060002
KIT D816V ASSAYARUP LABARATORIES2015-12-18H140006