Humanitarian Device Exemption (HDE)
Navigating the FDA regulatory process for Humanitarian Use Devices (HUDs) can be complex. Our services are designed to guide you through each step, from obtaining HUD designation to marketing authorization.
What is a HUD?
A HUD is a medical device intended to benefit patients by treating or diagnosing diseases that affect no more than 8,000 individuals in the U.S. annually. These devices can be approved through a Humanitarian Device Exemption (HDE), which does not require the manufacturer to provide results of scientifically valid clinical investigations demonstrating the device’s effectiveness prior to marketing.
Our Services
- HUD Designation: We assist in submitting an application to the FDA’s Office of Orphan Products Development (OOPD) to obtain HUD designation for your medical device.
- Unique Positioning: We help confirm that there are no other comparable devices legally marketed for the same intended use, except for other approved HUDs.
- HDE Application: We aid in preparing and submitting an HDE application to the appropriate FDA premarket review center, which includes data supporting the safety and probable benefit of the device.
- FDA Review: We support during the FDA review process to assess the device’s safety and probable benefit for the limited patient population.
- Marketing Authorization: If the FDA determines that your HDE application meets the necessary criteria, they may grant marketing authorization, allowing you to market and distribute the HUD.
Why Choose Us?
Our team of experts understands the intricacies of the FDA regulatory process and is committed to helping you successfully bring your HUD to market. We provide guidance on the required contents for the HDE application and potential FDA review actions. Trust us to navigate the regulatory landscape and help bring your innovative medical device to those who need it most.
Contact us today to learn more about our FDA regulatory services for HUDs. Let’s work together to make a difference in patients’ lives.
About Accel
Accel Groups is a dedicated team of seasoned professionals in regulatory, clinical and market access. We help medical device and IVD manufacturers with complete product life cycle solutions from preclinical, strategy, clinical evaluation and trial, regulatory submission, to post market surveillance. Our regional principals have a minimum of 10+ years’ experience in their specialty to enable us to provide the regional in-depth expertise but with global one-stop shop solutions. Ask us about our Start-up kits for start-up companies with key countries regulatory pathway.
