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Agencies May Not Rely On Flawed DCAA Audits

Client Alert | less than 1 min read | 02.04.10

In McKissak+Delcan JV II (Jan. 13, 2010), GAO for what may be the first time rejected a DCAA determination that the offeror’s accounting system was inadequate and sustained the protest because the agency had improperly relied on DCAA’s determination in rejecting the offeror’s proposal. Adequacy of business systems is an element of an agency’s responsibility determination when evaluating proposals, and bid protests are likely the only viable forum for contractors to contest findings of system inadequacies.

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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. ...