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Risk Assessment and Post-Market Programs
How do the medical device industry and the FDA prevent risks to the end user once the product is marketed? There is no simple answer to this question. Post-market vigilance in terms of risk assessment involves complex issues. These issues involve a cost/benefit analysis in terms of a “best approach” to post-market co-vigilence. The FDA has specified programs in terms of post-market risk prevention. For example, the 1976 Medical Device Amendments, the 1990 Safe Medical Device Act and 1992 Medical Device Amendments have served as milestones in medical device legislation, resulting in a system in which manufacturers must track the device from manufacture through distribution to assure accurate tracing in the event of problems. The regulations for tracking are found in 21 CFR Part 821.
The Food and Drug Administration Modernization Act of 1997 went even further in terms of legislating a medical device surveillance network for adverse events. The system, called MedSuN, is aimed at improving the protection of the health and safety of patients, users, and others involved with medical devices. The Medical Device User Fee Modernization Act of 2002 (MDUFMA) went still further on the subject of post-market surveillance in terms of Congressional appropriations and accountability.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.
Compliance Officers: Recent Regulatory Guidance and Enforcement Actions and Mitigating the Risk of Personal Liability
This article explores legal developments over the past year that may impact compliance officer personal liability.
Bankruptcy Sales: Finding a Diamond In the Rough
There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.