Knowledge base

Medical Devices

the FDA regulates the safety and effectiveness of medical devices, the packaging and labeling that describes how they should be used, and the facilities that manufacture them. FDA’s requirements for approving devices for marketing depend on the device’s potential for harming patients. Class I, or low-risk, devices include such things as elastic bandages and orthopedic saw blades. Class II or medium-risk devices, include items like urethral catheters and blood pressure cuffs. Class III, or the most stringent regulatory control for devices, such as heart valves and balloon angioplasty catheters, support or sustain human life and present significant risk of patient injury. Most Class I devices can be marketed without obtaining prior approval from FDA. FDA requires the manufacturers of most Class II and Class III devices to submit either a premarket notification application (510(k)) to show that the device is substantially equivalent to one already on the market or an application for premarket approval (PMA), which provides evidence, often including clinical data, demonstrating that the device is safe and effective. Qui Tam lawsuits have been successfully brought for off-label and kickback violations by the manufacturers of medical devices. Other scenarios include unapproved devices and clinical trial fraud.

    Contact Us

    Contact Us

    The more detailed the response, the more likely it is that we will be able to evaluate and determine if your potential False Claims Act case falls within our case requirements. IF IT DOES, WE WILL RESPOND TO YOU WITHIN 24 HOURS. (Names of potential defendants are not necessary at this point, should you feel more comfortable omitting them.) By law, all communications to us are 100% confidential.

    No. of Employees at the Company?
    Please read the following statement and then click "Send Form":

    Any response to your e-mail will be solely to communicate about our possible representation of you under the qui tam provisions of the False Claims Act. All e-mails submitted to us, whether we take your case or not, are 100% confidential. If we do not respond to your e-mail, then you have communicated information which we cannot address because it appears to fall outside of the False Claims Act or our case requirements.