Pre-Market Approval or 510(k)? You need to know

Many lawyers and clients ask the question “Can you sue a medical device company if the medical device has been approved by the Food and Drug Administration (FDA)?” My answer is “It depends on what process was used to approve the medical device”. PMA or 510(k)? You need to know It accounts for about 4,000 products a year that are classified as moderate risk to patient safety.

Then I ask “Was the failed product a PMA device or a 510(k) device?” Currently, patients can’t file lawsuits against medical device makers when their products were approved by the FDA using the Pre-Market Approval (PMA) process. Seems like most medical device companies would opt for the PMA process since they can’t be sued if their products failed after having been approved by the FDA’s PMA process. Not so. Only a fraction of the medical devices are approved under the more stringent and time consuming PMA process as opposed to the 510(k) faster track. It takes more time under the PMA process because the PMA process requires clinical tests and inspections.

Most medical products currently on the market have been “cleared” in the FDA’s 510k process. This process is hugely favored by the medical device industry. It accounts for about 4,000 products a year that are classified as moderate risk to patient safety.

Under the 510(k), applicants ask FDA examiners to approve a new device because it is “substantially equivalent” to an existing device, called a predicate. This process requires manufacturing companies to provide information to the FDA for evaluation of the proposed mesh. Characteristics of the new devices, such as biocompatibility, are included from studies usually funded by the companies themselves. The common practice is for the manufacturer to determine which previously FDA-cleared product their new product is most similar to. If the FDA agrees, a predicate is established, cleared and labeled as an equivalent product.


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The 510(k) process has been criticized by patient and consumer advocacy groups for years because so often the process approves what prove to be dangerous products. These products such as the Stryker Orthopaedic’s Rejuvenate and ABG II hip implant systems, Mentor Corportation’s Mentor ObTape, Johnson and Johnson’s DePuy ASR hip, and Boston Scientific’s ProteGen Sling have been proven failures. And, they haven’t just destroyed lives and cost patients billions of dollars in medical costs, since these products are typically used in older populations, taxpayers through Medicare have often been left to foot this extraordinary bill!

By: Mark DiCello