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2023 was a busy year across several federal agencies in terms of issuing compliance guidance for corporations, including health care companies. For example, the Department of Justice...
DOJ announced corporate compliance policy updates. Policy is further effort to offer transparency, predictability, and to encourage self disclosure of wrongdoing. Assistant Attorney General Polite issued CEP revisions and DOJ published Voluntary Self Disclosure Policy USAOs.
FDA launched the Pilot Program to study whether information collected at multiple points during the total life cycle of a software product could be an efficient and successful approach to assess the safety and effectiveness of medical device technologies.