Viewed broadly, increasing compliance requirements are part of an array of steadily growing pressures that the medical device industry faces, including rising product development costs and greater pricing sensitivity. Regulations and enforcement actions on a variety of compliance issues, including conflicts of interest, rising product prices, product safety, distributor agreements, and direct-to-consumer advertising are becoming more stringent, and this trend shows little sign of abating. At the same time, concerns about safety are driving new regulatory requirements, such as the Food and Drug Administration Amendments Act of 2007’s (FDAAA) new clinical trial reporting requirements and FDA authority to require post-market surveillance studies. Given the impact of an investigation in terms of time, cost, and potential liability, ongoing proactive compliance measures are an imperative. What’s clear from these trends is that regulators expect companies not only to have compliance programs, but to be able to demonstrate the effectiveness of their compliance efforts. The greater challenge, however, is to ensure effective compliance practices and to use compliance requirements strategically.

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