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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.
Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It
Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?
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.
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.
A Lawyer's System for Active Reading
Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.
Protecting Innovation in the Cyber World from Patent Trolls
With trillions of dollars to keep watch over, the last thing we need is the distraction of costly litigation brought on by patent assertion entities (PAEs or "patent trolls"), companies that don't make any products but instead seek royalties by asserting their patents against those who do make products.