Baton Rouge Medical Device Injuries Attorney
Sometimes, things with medical devices don’t go as planned, and people sustain medical device injuries. There are often FDA recalls of particular products, which leads to so many people experiencing issues that class action cases are started. Sometimes, the manufacturer admits liability and sets up a pool of money to pay for victim’s claims – including often replacement or repair of the device.
InjuredGo.com Law Firm, LLC wants to help you if you have a defective medical product.
Please Select Your Device Below. If you are having a problem with a medical device and it is not listed, please Contact Us for a free consultation and see if we can assist you.
What Can YOU Do If You Are A Victim of One of These?
InjuredGo.com Personal Injury Law Firm can help you navigate the complex and often complicated world of faulty or defective medical devices.
There are some government resources and regulatory bodies for medical devices. For example, the FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating firms who manufacture, repackage, relabel, and import medical devices sold in the United States. Also, CDRH regulates radiation-emitting electronic products (medical and non-medical) such as lasers, x-ray systems, ultrasound equipment, microwave ovens and color televisions.
Medical devices are classified into Class I, II, and III, however, regulatory control increases from Class I to Class III. The device classification regulation defines the regulatory requirements for a general device type, whereas most Class I devices are exempt from Premarket Notification 510(k), however, most Class II devices require Premarket Notification 510(k). Most Class III devices require Premarket Approval. A description of device classification and a link to the Product Classification Database is available at “Classification of Medical Devices.”
The basic regulatory requirements that manufacturers of medical devices distributed in the U.S. must comply with are:
- Establishment registration,
- Medical Device Listing,
- Premarket Notification 510(k), unless exempt, or Premarket Approval (PMA),
- Investigational Device Exemption (IDE) for clinical studies
- Quality System (QS) regulation,
- Labeling requirements, and
- Medical Device Reporting (MDR)
Call or contact us for a free case evaluation.