FDA’s Process for Approving Medical Devices under Review

Medical devices are a crucial part of American Healthcare.  Some medical devices are simple everyday products such as bandages and contact lenses, but other medical devices are complex items such as hip implants, knee implants, pacemakers, or heart-lung machines.  The use of complex medical devices such as hip implants and knee implants are becoming far more common, and we are relying on them to improve the length and quality of our lives.  Therefore, it is more important than ever to make sure that these devices are safe.  When it comes to making sure that medical devices are safe, we rely on the Food & Drug Administration (“FDA”).

For the past 35 years the FDA’s 510(k) clearance process, named for § 510(k) of the Federal Food, Drug, and Cosmetic Act (“FFDCA”), has been the safety net used to make sure that medical devices are safe for consumers.  The FFDCA requires a “reasonable assurance of safety and effectiveness” before a medical device can be marketed, and devices that are deemed to have a moderate risk to patients must generally be cleared through the 510(k) process.

Due in large part to a recent wave of medical device recalls such as the DePuy Orthopaedics ASR XL Acetabular Hip Implant, the FDA has recently begun to evaluate the effectiveness of the 510(k) clearance process.  In August of 2010, the FDA’s Center for Devices and Radiological Health (“CDRH”) released for public comment a preliminary report from the 510(k) Working Group and Task Force on the Utilization of Science and Regulatory Decision Making.  The Committee explored actions that the CDRH could take to enhance the effectiveness and predictability of the 510(k) process.  On January 19, 2011, the CDRH published its 510(k) and science report recommendations which included 25 action items that the CDRH intends to implement during 2011.  CDRH also noted that it would give the Institute of Medicine (“IOM”) an opportunity to weigh in on certain recommendations. 

Recently, in July of 2011, the IOM Committee on the Public-Health Effectiveness of the FDA’s 510(k) clearance process provided its feedback. The IOM’s report concluded that the 510(k) process is generally not intended to evaluate the safety and effectiveness of medical devices and cannot be transformed into a pre-market evaluation of safety and effectiveness.  Therefore, the report recommended steps to scrap the outdated process and develop a more rational medical device regulatory framework. 

Consumer advocates eager to protect those who may be harmed by unsafe medical devices applaud the IOM’s effort to provide a reasonable assurance of safety and effectiveness before complex medical devices are placed on the market.  On the other hand, the manufacturers of medical devices may be concerned that more stringent regulation would make it difficult for their products to reach the market place.  As the battle between safety and profits continues to be waged, the lawyers at Pope McGlamry remain committed to helping victims of unsafe medical devices.

If you or a loved one has suffered an injury from an unsafe medical device, you may be entitled to compensation for medical bills, pain and suffering, lost wages and other injuries.  Currently Pope McGlamry is reviewing injuries related to artificial metal-on-metal hip replacements manufactured by DePuy Orthopaedics, Inc., Zimmer and Wright Medical Technology, Inc.  Contact one of our Georgia medical device lawyers or visit our website www.pmkm.com.