How Medical Device Cos. Can Limit Enforcement, Legal Risks

By Lisa Smith, Eric Kraus and Michelle Bonn (December 21, 2021, 6:44 PM EST) -- Regulatory compliance is key for avoiding governmental enforcement actions and litigation risk.

In this article, we examine the myriad ways in which the failure to abide by even the simplest process and procedure regulations promulgated by the U.S. Food and Drug Administration can result in significant, even devastating, financial loss to a company.

From FDA Form 483s to warning letters and product recalls, understanding the regulatory landscape is critical to ensure uninterrupted product production and sales. We discuss one case study to illustrate how regulatory violations can lead to injunctive relief, product recalls and product liability litigation. We then address best...

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