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NAICS Challengers at Court Must First Exhaust Administrative Remedies

Client Alert | less than 1 min read | 04.27.15

On April 22, 2015, the Federal Circuit ruled in Palladian Partners, Inc. v. U.S. that, although the Court of Federal Claims has jurisdiction to review challenges to NAICS code decisions made by the SBA's Office of Hearing and Appeals (OHA), in order for an offeror to challenge such a decision at the court, the offeror had to have participated in the appeal at OHA brought by a different offeror. Here, because the offeror failed to do so, the offeror had not exhausted its administrative remedies, and the case was remanded to be dismissed.


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Client Alert | 6 min read | 09.03.26

FDA Seeks Input for Regulating GenAI-Powered Medical Devices

The U.S. Food & Drug Administration (FDA) is seeking feedback on a regulatory framework that could be used to evaluate generative artificial intelligence (GenAI)-enabled medical devices. Such devices could create new types of risks because their outputs can vary and evolve, unlike more traditional software-enabled devices. An August 18, 2026, discussion paper (“Considerations for the regulation of GenAI-enabled medical devices”) discusses potential regulatory considerations for GenAI-enabled medical devices. ...