Federal regulators have recently issued new guidelines for a controversial fast-track approval process known as 510(k), which some say has been misused by many medical device manufacturers as it poses a risk of allowing dangerous medical devices to enter the market without thorough testing. However, on July 28, 2014, the U.S. Food and Drug Administration (FDA) issued a new guidance for both the medical device industry and its own personnel on a crucial portion of the 510(k) pre-market approval program.
The FDA Updates Its Approval Guidelines
The new guidelines state how the FDA should determine whether a medical device is equivalent to an approved, existing device, which allows the manufacturer to place the product onto the market without first conducting rigorous premarket trials. The FDA also released a guide on the benefit-risk factors that should be considered when determining what the “equivalent” is for products that have technological differences.
In the new guidance, the agency defines “equivalent” as having the same technological characteristics and the same intended use as the predicate device. If it has different characteristics, the manufacturer must show that the device is effective and safe and that the changes do not give way to questions of the effectiveness and safety of the original device on which the new product is based.
About the 510(k) Clearance Process
Many medical device manufacturers have obtained FDA approval for devices like transvaginal mesh and hip replacements by:
- Asserting that they are nearly identical to previously approved devices
- Claiming that they are vast improvements that utilize new materials or revolutionary designs
- Claiming that they have engaged in marketing that extolled the virtues of the devices
While the 510(k) clearance process was initially designed for non-critical medical devices like tongue suppressors and band-aids, the program has expanded in recent years to include numerous medical devices, including stents, defibrillators, artificial joint implants, surgical mesh, and other products that are implanted into the body. The program has come under fire recently due to the number of recalls involving 510(k)-approved devices, which were only found to carry severe risks after patients throughout the country had already been fitted with them.
Importance of Seeking Legal Counsel
Those who have been injured by a medical device may wish to pursue claims against manufacturers to seek compensation for their injuries. If you or someone you love was harmed by one or more of the following products, contact Attorney Group to learn more about your options:
- da Vinci Surgical System
- Mirena intrauterine device
- Transvaginal mesh
- Metal-on-metal hip replacements
Have You Been Injured by a Defective Medical Device? Contact Us Today
If you or a loved one sustained injuries and you believe that a defective medical device is to blame, contact Attorney Group to learn about your options. We provide free case evaluations to those who have developed complications due to an allegedly defective medical device, and we can help determine whether you may be eligible to recover damages for your injuries. If you have a case, we can connect you with one of our defective medical device attorneys who can help you seek the compensation to which you may be entitled.