Expert Analysis

Expert Analysis


Medical Device Regulatory Reform Continues to Deepen in China

China’s medical device regulation is undergoing remarkable change. In March 2014, China’s State Council promulgated a significant revision to the framework regulation governing medical devices, the Medical Device Supervision and Administration Regulations MDR). The revised MDR left many of the core aspects of the medical device regulatory regime intact. However, it also made a number of structural changes and adjustments to past practices that have already had, and will likely continue to have, a significant impact on stakeholders. Read More

Are Your Marketers Taking Advantage Of FDA's Internet/Social Media Guidances?

Last year, the FDA issued two new draft guidance documents, one on use of internet platforms with character space limitations and one on how to correct third-party misinformation about drugs or devices online. These guidance documents were long awaited by industry. Meetings about the need for such guidance date back to November 2009, and they were mandated under the Food and Drug Administration Safety and Innovation Act of 2012. Read More

The New Notified Body Environment In the EU — First Reflections

Following the discovery of the fraudulent use of nonmedical-grade silicone in breast implants manufactured by Poly Implant Prothèse in France, European Health and Consumer Policy Commissioner John Dallí called on member states to take immediate action to ensure “full and stringent implementation” of the current medical device directives.1 The resulting Joint Plan for Immediate Actions proposed to the member states joint actions aimed at tightening controls on medical devices in the framework of that legislation, focusing on four pillars: the functioning of notified bodies, market surveillance, coordination of corrective actions among member states following vigilance and market surveillance, and communication and transparency. Read More

Medical Devices in India Under Prime Minister Modi: What Can Industry Expect?

The medical device industry in India has historically operated in the shadow of the generic pharmaceutical industry, which has branded itself as the “developing world’s pharmacy” along with a significant focus on exports to developed countries such as the United States. In fact, the Founder of Sun Pharmaceuticals, Dilip Shanghvi, is one of the richest persons in the world following his company’s acquisition of Ranbaxy Pharmaceuticals earlier this year. As such, the generic drug industry has been a darling of key decisionmakers in India, including the Office of the Prime Minister. Read More

The Impact of Off-Label Promotion on Product Liability

Companies that engage in off-label promotion dramatically increase the risk of facing expensive judgments in product liability lawsuits. Read More

Keep Up With Investigator Tactics, Regular Training to Pass Inspection

Devicemakers have a better shot at emerging from an FDA inspection unscathed if they watch for common investigator tactics, such as stepping away from the company contact, an expert says. Read More

Recall v. Enhancement Guidance Puts Companies Between Rock, Hard Place

The FDA’s draft guidance on distinguishing recalls from product enhancements contradicts current regulations, creating “a new sort of burden for industry,” an attorney says. Read More