Anson Group
Using an HDE to Enhance the Value of a Medical Technology Product

Background

A Humanitarian Device Exemption (HDE) is an alternative to PMA for FDA approval of medical devices intended for uses with diseases that affect relatively small patient populations to whom no similar devices are available. HDE approvals require documentation of probable patient benefit. PMAs must provide clinical proof of effectiveness, generally a far longer and costlier undertaking. To be eligible for HDE approval a device must first be designated as a Humanitarian Use Device (HUD) by FDA, and contain specific labeling just for HDE devices.

Case Study

A venture-funded development stage client was developing a technology for treatment of certain neurological disorders that presented significant market potential. In the interim, the company asked Anson Group for help in pursuing a PMA path to commercialize the technology for treatment of another, relatively low incidence disorder. Aware of the company’s long term business goals, we investigated alternatives and persuaded the client to allow Anson to seek HUD designation for the device. A complicating factor was the existence of an already approved device for treating the same disorder. The approved device required irreversible surgery; our client's device did not.

After filing a request with FDA, Anson listened carefully to the Agency anticipated initial position that the existence of an approved similar device precluded HUD designation for our client's device. Over a period of a few months, Anson and the client presented evidence based on clinical experience and medical literature and regulatory precedent, and built a successful case, within the framework of the HDE regulations, that the existing device was not clinically similar. HUD designation was granted and Anson's client is proceeding on the HDE path.  

Benefit to the Client

  • Anson Group's focus on the client's longer term business goals led to identification of potentially faster and much less costly route to achieving an interim development goal.

  • Our consultants' familiarity with FDA regulatory practice and precedent, as well with the letter of the regulations, enabled them anticipate and to obtain the necessary approval for the client to proceed.

  • The HDE approval project will provide the client with early pre-clinical and clinical safely data that will accelerate development and approval of the key products it ultimately plans to market.

  • The present value of the client's technology has been enhanced by reducing the future product approval regulatory risk.
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