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Medical devices can vary from relatively simple items like gauze & bandages to extremely complex devices like hip replacements and pacemakers. However, regardless of a device’s simplicity or complexity, it must be evaluated by the FDA prior to its introduction to the market. While there are some limited exceptions, generally speaking there are two approval processes to which a proposed medical device can be subjected to: pre-market approval & pre-market evaluation. While the review procedure’s goal is to screen out defective or ineffective medical devices, mistakes can be made that significantly increases the risk of personal injury or wrongful death. If you have suffered an injury or the loss of a loved one due to a defective medical device, the Law Practice of Ken Kieklak can fight to hold the responsible parties financially accountable.
This post will focus on the pre-market evaluation process utilized by the FDA.
How does the FDA classify devices?
In general, the FDA assigns medical devices a class depending on the risk of the device. Class I devices are of the lowest level of risk. Examples of common class I devices include tongue depressors, bandages, and reading glasses. Class II devices have higher level of risk than class I devices and can include medical devices like electrocardiographs and thermometers that utilize mercury. Class III is reserved for devices with the highest level of risk. Class III devices are often complex and can include devices such as an artificial heart valves and a pacemaker. Class I and Class II devices that require premarket review generally proceed through the premarket notification process also known as the 510(k) process. Furthermore, class III devices in distribution prior to May 28, 1976 and devices substantially equivalent to those pre-amendment devices may qualify through the 510(k) pre-market evaluation process.
For a medical device to achieve substantial equivalence or to be deemed substantially equivalent the device must have the same intended use as another legally marketed device and the same technological characteristics. If a device has the same intended use but different technological characteristics then information that demonstrates that the device is as safe and effective as the legally marketed device and does not raise different questions of safety or effectiveness must be submitted. See 21 U.S.C. § 360c(i)(1)(A).
What is the 510(k) process?
The 510(k) process is designed to encourage high-quality submissions and expedient review of applications. A finely-tuned review process permits life-saving and life-improving medical devices to reach consumers more rapidly. As such the process provides rapid feedback. 510(k) applicants can expect an initial criteria-based review within 15 days. This initial review is called an Acceptance Review. The Acceptance Review will let the submitter know if the application will proceed to the Substantive Review or if it will be placed on RTA Hold.
If the review proceeds to the Substantive Review Phase a comprehensive review of the device is carried out. A submitter should expect a response within 60 days which can include an Interactive Review or a request for additional information (AI). The Interactive Review process can be utilized to address outstanding deficiencies when the deficiencies can be corrected within 90 days. If an AI request is made, the application is put on hold. The submitter has 180 days to respond or the request for approval will be withdrawn and the process will have to begin again. Most 510(k) applications are resolved within 90 days.
Put our defective medical device experience to work for you
While medical devices are subject to regulation and review, widespread use of these products can often reveal previously unknown defects and safety issues. If you have been injured by a medical device like a pacemaker, artificial heart valve, or pelvic mesh the Law Practice of Ken Kieklak can stand-up for your rights. We work to secure financial compensation for your severe injuries. To schedule a free and confidential consultation, call (479) 251-7767 or contact us online today.
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