HDE — Humanitarian Device Exemption
US-unique
The HDE is a US-specific pathway with no direct equivalent in other major jurisdictions. It is analogous to an orphan drug designation but for medical devices.
What is HDE?
The Humanitarian Device Exemption (HDE) is a marketing approval for a Humanitarian Use Device (HUD) — a device intended to benefit patients with diseases or conditions that affect ≤8,000 individuals per year in the USA.
Regulated under 21 CFR Part 814, Subpart H and FD&C Act § 520(m).
HDE vs PMA
| Feature | HDE | PMA |
|---|---|---|
| Patient population | ≤8,000/year in USA | Any size |
| Effectiveness standard | Probable benefit (not "reasonable assurance") | Valid scientific evidence |
| Profit restrictions | May not generate profit without IRB approval (waived for pediatric devices) | No restriction |
| Application fee | Reduced | ~$430K |
HUD designation process
Before submitting an HDE, the device must receive HUD designation from FDA's Office of Orphan Products Development (OOPD):
- Submit HUD designation request to OOPD
- OOPD reviews and grants or denies (typically 90 days)
- Once designated, submit HDE application to CDRH
HDE application contents
An HDE application is similar to a PMA but uses the "probable benefit" standard rather than "reasonable assurance of effectiveness." It requires:
- Device description and indications for use
- Non-clinical and available clinical data
- Risk-benefit analysis
- Manufacturing information
- Labelling
- HUD designation letter