This explains the differences between the regulatory pathways for a Humanitarian Use Device (HUD) or HDE and 510k submissions.

HDE Application

In September 2019, the FDA released a final guidance document explaining the regulatory process for a Humanitarian Device Exemption (HDE) Application. HUD designation is for a product that affects less than 8,000 patients per year in the United States. The limitation of 8,000 There are three steps required before a HUD may be used at a user facility:

1. HUD Designation Request to Office of Orphan Products Development (OOPD)
2. HDE Application to Center for Devices and Radiological Health (CDRH)
3. Investigational Review Board (IRB) approval of using the HUD

Note: The above regulatory pathway may not apply to combination products. In the case of combination products, you should contact the Office of Combination Products (OCP).

Major Differences between the HDE Application and a 510k submission

• 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. In contrast, the first requirement for the determination of substantial equivalence of a subject device for a 510k submission is that the predicate device must be a legally marketed device that is equivalent.
• There are no user fees, while 510k submissions generally are subject to FDA user fees; pediatric-only products are an exception to the requirement for 510k user fees.
• There is no requirement to demonstrate the effectiveness of devices in an HDE application. Instead, devices approved for HDE must provide an acceptable benefit/risk analysis.
• HDE-approved devices are not generally eligible to make a profit. Any device that a manufacturer intends to sell for more than $250 requires a report issued by an independent public accountant.
• IRB approval for the use of HUD-approved marketing is required, but IRB approval is not for a clinical study, and IRB approval is not required in the case of an emergency.

The FDA guidance document also explains how HDE approval is different from pre-market approval (PMA).