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Ethics are inexorably linked to innovation and the release of new technology in the medical device industry. This work explores the ethical responsibilities of the actors within the industry, and questions the effectiveness of 510(k) regulation to adequately and ethically regulate the release of medical devices. Revision or redefinition of 510(k) policy is strongly suggested to properly address concerns of safety and efficacy in the ethical release of innovation to the public. This analysis should further the discussion of public policy changes in the medical device industry which are needed to protect patients and more ethicially drive the release of new products.