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Humanitarian Device Exemption (HDE)

HDE approval is based on demonstrating a reasonable assurance of safety and probable benefit; PMA approval is based on demonstrating a reasonable assurance of safety and effectiveness. Demonstration of probable benefit may be accomplished from the literature and may not require submission of any clinical data.

FDA Authorization of Medical Devices Class I devices are low-risk devices. Examples include bandages, handheld surgical instruments, and nonelectric wheelchairs. Class II devices are intermediate-risk devices. ... Class III devices are high-risk devices that are very important to health or sustaining life.

Unlike the 510k process, HDE approval is device approval rather than “clearance” for marketing and distribution. If another equivalent (an actual term used is “comparable”) device is already being legally marketed, then the FDA may not approve an HDE application.

Humanitarian Device Exemption (HDE) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.

Some devices may be exempt from IDE regulations under 21 CFR 812.2(c). Generally, a device is considered exempt if it is non-invasive and not used to perform invasive sampling procedures. The ultimate decision on which classification a medical device receives falls on the FDA.

An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA.

In order to address this challenge, Congress included a provision in the Safe Medical Devices Act of 1990 to create a new regulatory pathway for products intended for diseases or conditions that affect small (rare) populations. This is the Humanitarian Device Exemption (HDE) Program.

Humanitarian Use Device (HUD): 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 (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255).

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is as safe and effective as the predicate. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
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Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232