AdvaMed Weighs FDA Draft Guidance on HDE Program

Regulatory NewsRegulatory News | 13 August 2018 |  By 

Medical device industry group AdvaMed took issue with several parts of a recent draft guidance from the US Food and Drug Administration (FDA) on its humanitarian device exemption (HDE) program.

In comments released Monday, AdvaMed said it disagreed with FDA’s position on what should be considered valid economic factors to determining profit eligibility, while also taking issue with a lack of clarity that randomized controlled trials are not necessary to demonstrate probable benefit.

“To demonstrate probable benefit, standard of care comparators can be used along with statistical methodologies such as propensity matching, group comparison designs, etc.,” AdvaMed said. “The cost of opening and managing many investigational sites discourages companies from even considering the HDE pathway, particularly if profit is prohibited. As just one example, one company incurred costs of $15 million for a 40-person pediatric study at 15 sites. FDA should allow these economic considerations to be a factor.”

The statute requires that humanitarian use devices (HUDs) can only be administered in facilities with properly constituted and functioning IRBs, AdvaMed noted, which means insurers assume the HDE must be an investigative device not eligible for private insurer reimbursement.

“As a result, many times, costs associated with HUDs are out-of-pocket for patients and their families,” AdvaMed said, while commending the agency for keeping language in the draft guidance that makes clear that approval of a HDE is considered FDA approval of the device.



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