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Proposed DFARS Rule to Provide Guidance on Assessing Commercial Price Reasonableness

Client Alert | less than 1 min read | 08.05.15

On August 3, the DoD issued a proposed rule, with comments due by October 2, to amend the DFARS to clarify the amount and types of data that contracting officers may require from contractors in order to perform price reasonableness assessments for commercial items. The proposed rule addresses (1) the conditions under which prior sales information is sufficient, (2) when "uncertified cost data" will be required and the required format, and (3) the limits on requiring additional cost information when there are "sufficient nongovernment sales to establish reasonableness of price."


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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. ...