Unduly Restrictive Specification Requires Redo
Client Alert | less than 1 min read | 03.24.15
In Smith and Nephew Inc. (Jan. 2, 2015), publicly released this week, GAO sustained a pre-award solicitation protest alleging that the VA had unduly restricted competition with an unnecessary specification requirement. GAO concluded that the "minimum fluid absorption rate" for medical bandages demanded by the VA was not based on any demonstrable agency need, was predicated on one repudiated test study by a single contractor, and could not be met by any commercially available product in the marketplace.
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On December 17, 2025, the U.S. Food and Drug Administration (FDA) issued a request for information (RFI) on a proposal designed to help the FDA engage more directly with innovative, venture-backed companies focused on biotechnology, medical devices, AI, and regulatory technology.[i]The RFI includes 19 questions, with responses due by 2:00 p.m. ET on January 18, 2026.
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