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.