Understanding the FDA Approval Process for Medical Devices

Greenville and Spartanburg, South Carolina

The FDA performs a number of important functions. One of these is making sure that medical devices are safe for use with patients before they can receive approval. Unfortunately, the FDA approval process for medical devices is highly flawed. As a result, it is common for devices to receive approval, even when they contain defects which jeopardize the health and safety of patients.

In recent years, several hip implant devices have been recalled due to alarming failure rates and other serious complications. If you have suffered an injury caused by a defective Stryker hip implant or DePuy hip implant, the hip recall lawyers at McWhirter, Bellinger & Associates can help you receive the compensation you deserve.

Please call 800-694-0994 today to schedule a free consultation at one of our South Carolina offices.

The Medical Device Approval Process

The FDA approval process varies based on the classification of a particular medical device. There are three different medical device classifications:

  • Class I Devices – Low risk devices such as canes, rubber gloves, stethoscopes and other similar medical instruments. These medical devices are not subject to FDA approval.
  • Class II Devices – Complex, moderate-risk devices which are not considered life-sustaining. The overwhelming majority of medical devices subject to approval fall into this classification. Examples include surgical lasers, medication pumps, and hip implant devices.
  • Class III Devices – High-risk devices which serve the purpose of sustaining life, such as defibrillators or pacemakers. Approximately 1% of medical devices receive this classification.

Class III devices must pass through a very rigorous approval process called pre-market approval (PMA). During this process, the medical device manufacturer must present scientific data from clinical trials which establish that the device is safe and effective for use with patients.

Class II devices, on the other hand, are able to bypass the PMA process. Instead, they are approved under the controversial 510(k) process which simply requires the manufacturer to demonstrate that their device is “substantially equivalent” to another device that has already received approval. Under the 510(k) process, manufacturers do not have to submit safety data from clinical trials, significantly increasing the risk that a dangerous device will be approved for use.

Problems with the FDA Approval Process

There are several problems with the 510(k) process. There is very little consistency regarding the standards used to demonstrate that a device is “substantially equivalent” to another one already on the market. In some instances, engineering diagrams and material science studies must be submitted; in others, very little documentation, if any, is required. As a result, devices may be deemed “substantially equivalent” even when there are significant differences in the materials used, manufacturing process, or intended uses of the two devices.

In addition, when defective medical devices are recalled from the market, they are not removed from the approved list of devices. This creates a situation where new devices can receive 510(k) approval by being considered “substantially equivalent” to a recalled defective device. Clearly, this poses a serious danger to patients.

Our South Carolina hip recall lawyers understand the many complex issues associated with this flawed FDA approval process, and we have the vast resources necessary to help you build a strong case that will hold negligent hip implant manufacturers accountable for your damages.

Please contact McWhirter, Bellinger & Associates today to schedule your free consultation. We serve clients in Greenville and Spartanburg, South Carolina.