Implantable medical devices offer invaluable benefits to individuals suffering from a broad range of ailments. They help people breathe, they help people walk and they provide an enhanced quality of life that simply is not available through other forms of medical treatment. Unfortunately, they can also be dangerous. Over the […]

In this fifth and final installment of our series on defective medical device issues, we are discussing the lack of a national device registry in the United States. Despite calls from various advocacy groups and some preliminary efforts at the federal level, the U.S. still lacks a central repository for […]

So far, our series discussing issues associated with defective implantable medical devices has focused on specific deficiencies in the U.S. Food and Drug Administration’s (FDA) approval and safety monitoring systems. First, we discussed the inherent conflicts of the 510k clearance process.  Then, we discussed the limited recall requirements for implantable […]

Did you know that 32 million Americans have at least one medical device implant? As the main regulatory agency charged with ensuring the safety and efficacy of drugs and medical devices, the Food and Drug Administration (FDA) is entrusted with the safety and well-being of countless Americans every day. Their […]

The Food and Drug Administration (FDA) has the responsibility to protect the health of U.S. consumers by ensuring food, drugs and medical devices are safe. The FDA also has a mission to advance the health of U.S consumers by speeding innovations of such products. The latter is the reason the […]

The U.S. Judicial Panel on Multidistrict Litigation (“JPML” or “The Panel”) is a body of seven federal district judges who manage multidistrict litigation, meeting on a bimonthly basis to consider requests to establish MDLs. The Panel has the authority to determine whether civil actions pending in two or more federal […]

A trio of studies published in the Journal of the American Medical Association (JAMA) finds that just because a drug or medical device makes it to market does not necessarily mean it’s been tested and is safe and effective beyond all doubt. According to three published reviews, the same standards […]

The Food and Drug Administration (FDA) held a meeting this week to consider whether the 510(k) approval process for medical devices is keeping the public safe while balancing the need of industry to get innovative products to the market faster and easier. “External stakeholders” were invited and helped set the […]

You might not realize that K-Y Jelly is a medical device but it is and the U.S. Food and Drug Administration (FDA) is not happy about claims made by Johnson & Johnson concerning the personal lubricant. As a result McNeil Consumer Healthcare, a subsidiary of J&J, has recalled 2.3 million […]

Apparently, the FDA will expedite its abbreviated 510K approval process.  The medical device industry is painting this as an improvement in the device approval process, but at what cost?  And, for who is this expedited clearance process an improvement? According to an analysis from the medical device consulting company Emergo […]