Office of Research Facilitation Policies and Procedures Frequently Asked Questions - Humanitarian Device Exemptions

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Q: What does HDE stand for?

A: Humanitarian Device Exemption

Q: Why is there a designation like HDE?

A: An HDE is a way for the FDA to make treatment available to a specific patient population that has few or no treatment options and in who the condition being treated occurs at a low rate (which would make conducting a clinical study of sufficient size and scope to obtain a marketing approval in a conventional fashion nearly impossible).

Q: How does an HDE differ from other marketing approvals like 510(k)s and PMAs?

A: To obtain an HDE a device must first be granted Humanitarian Use Device (HUD) status. This requires review by a small branch of the FDA that reviews the device’s intended use and the patient population that the device will be used to treat.  The patient population cannot exceed 4000/year.

Once the HUD has been obtained, the sponsor must then file a HDE in order to obtain marketing approval. This lengthy process involves submitting limited clinical information as well as supporting literature to help FDA make a decision about how safe the device is or if there is any probable benefit to the intended population.

The biggest difference in the HDE process from other marketing processes is that there is no predicate product [like in a 510(k)] for comparison and there is no requirement to definitively establish safety and effectiveness of the product [like in a PMA].

Q: Is IRB approval required to use an HDE device?

A: Yes. Unlike commercial devices marketed via 510(k) or PMA, IRB approval is required prior to use of an HDE device due to the limited clinical information available about the product.

Q: Is patient consent required?

A: By law, informed consent specific to use of the HDE device is not required. However, IRBs may require that patient consent, specific to use of the device, is obtained.  In these cases, physicians must abide by the rules set forth for their institution by the reviewing IRB.

Q: How do I report complaints or complications?

A:  The device manufacturer will have special forms for you to fill out if you have a complaint or need to report an incident involving an HDE device.  Like other commercialized devices, HDE devices are also subject to MDR regulations and you should report events through the MDR system like you do for any commercialized device. If further information is required regarding filing of MDR reports, you may find the document on the FDA website at www.fda.gov/cdrh by searching for ‘An Overview of the Medical Device Reporting Regulation.’

Q: Am I restricted in any way in how I use the product?

A: All the standard laws and regulations apply regarding use of the product. Use must be ‘on-label’ and only for the intended patient population described in the Instructions for Use Manual. Any other use of the device can result in cessation of product to your institution and a report of violation of the HDE to your reviewing IRB.

Q: Why is IRB approval required for a market released product? Won't my IRB think that this is unusual?

A: IRB approval is required for a HDE because of the special circumstances that govern approval and use of a HDE device. Because a randomized clinical trial was not performed on the product, FDA made a determination of the relative safety of the device and the probable benefit to the patient from the data that was available. However, FDA expects that final decision as to that probable benefit vs. the risks, in that institution, rests with the IRB. Also, the patients who typically qualify for receipt of an HDE device have few options and the FDA wants to make certain that patients are treated appropriately given the compromised medical condition that qualify them for use of the device. By requiring IRB approval, FDA is allowing the review board to make the final decision as to whether or not the device should be used by their physicians and to have a prospective dialogue with the physicians regarding its use.

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