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# Suggestions for HDE Draft Guidance Changes
- URL: https://www.fdaweb.com/suggestions-for-hde-draft-guidance-changes/
- Published: 2018-08-15T12:00:00.000Z
- Updated: 2026-09-15T00:26:01.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5142116

The BRIDGE Coalition (Bringing Real-world Insight for Device Governance and Evaluation), a coalition of medical device companies, [says](https://www.regulations.gov/document?D=FDA-2014-D-0223-0019&ref=fdaweb.com) it supports the increased institutional review board flexibility included in a draft FDA guidance on the humanitarian device exemption (HDE) program. It also supports the agency’s efforts to further define probable benefit, but believes that further clarification is needed, as the draft guidance currently drafted provides a convoluted definition that may create inconsistencies in implementation/application. Further clarification also is needed, the coalition says, on the process for requesting an exemption from the restriction on profitability for pediatric only devices.

In its comment [letter](https://www.regulations.gov/document?D=FDA-2014-D-0223-0014&ref=fdaweb.com), AdvaMed says the final guidance should make clear that prospective randomized controlled trials are not necessary to demonstrate probable benefit. “Randomization in the pediatric population can be ethically challenging,” it says. “To demonstrate probable benefit, standard of care comparators can be used along with statistical methodologies such as propensity matching, group comparison designs, etc.” The trade group also says it disagrees with the FDA position on what may be considered valid economic factors to determine profit eligibility. It provides specific line-by-line comments on various elements of the draft.

The National Organization for Rare Disorders (NORD) [comments](https://www.regulations.gov/document?D=FDA-2014-D-0223-0020&ref=fdaweb.com) that it was pleased to see improvements to the HDE program in both the 21st Century Cures Act and the FDA Reauthorization Act of 2017\. “Namely,” it says, “we were supportive of the expansion of the program from devices that impact 4,000 patients to the current 8,000 patients and the requirement for FDA to issue guidance clarifying the use of the ‘probable benefit’ standard when making HDE determinations. We believe both changes will improve the program and increase the number of medical devices developed for those with rare diseases. We are appreciative of FDA’s proposed improvements to determining probable benefit. These improvements will not only hopefully lead to more regulatory certainty for humanitarian use device (HUD) developers but also, by including patient perspectives in the determination of probable benefit, should ensure innovative HUDs presented to FDA for review are truly patient-focused.”

The Cook Group provides [comments](ttps://www.regulations.gov/document?D=FDA-2014-D-0223-0018) on three areas of the draft—assessing probable benefit and risk, eligibility for profit, and the refuse-to-accept program.