NEW FDA Medical Device Regulations 2013
Posted on Jul 17, 2013
"Medical Device Reporting for Manufacturers" is a new guide from the Food and Drug Administration (FDA). The draft of the new guide was released last week and will replace the document last approved 15 years ago. Although not yet finalized, our medical malpractice lawyers in Raleigh reviewed the draft guide and have a breakdown of the key points that may affect consumers:
Serious injury. The MDR guide sets forth specific language that defines serious injury. The FDA defines a serious injury or illness as one "that is life threatening; results in permanent impairment of a body function or permanent damage to a body structure; or necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure."
Malfunction reporting. The terms of the MDR state that not every malfunction must be reported! Certain circumstances are required in order for reporting to be mandated. The specific affects of the device's performance must be taken into account: "The malfunction of a long-term implant is reportable only when the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur."
User error. Another important term involves user error, which is defined by the FDA as "a device-related error or mistake made by the person using the device. The error could be the sole cause of an MDR reportable event, or merely a contributing factor."
Some important changes include the removal of "Two-Year Rule" for Malfunctions. The new draft states that if manufacturers want to cease reporting malfunctions that previously contributed to a death or serious injury, the manufactuers would need to make a specific request to the FDA for an exemption. Special evidence requirements are set forth for this.
The guide also reviews regulations for medical device labeling, report requirements for facilities, importers and distributors of medical devices. If you believe you have suffered an injury or illness as a result of a medical device error and have questions about manufacturer liability, contact our medical malpractice lawyers in Raleigh at 877-BRENT-ADAMS for a free case evaluation.
Read more at the link below.