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The 510K is a pre-marketing presentation to the US Food and Drug Administration (FDA) to demonstrate that a consumer product is safe and effective - substantially equivalent to a legally available device. Requires a 510K notification to be demonstrated to be substantially equivalent to another legally marketed device in the USA. When it comes to substantial equivalence, it means that the new device is declared safe and effective. In other words, this new device means the device that has the same intended use as the equivalent device on the market, has the same technological features, has different technological features and does not raise different safety and effectiveness questions, and the information submitted to the FDA is as safe and effective as the legally marketed device show that. This equivalence claim does not require new and existing devices to be the same.
Following the information, the FDA first determines whether the new and anticipated devices have the same intended use and whether a difference in technological features creates different safety and efficiency problems. Then, it reviews the scientific methods used to evaluate the differences in technological features and performance data, and determines whether the device is as safe and effective as the equivalent device. In doing so, it examines a number of performance data such as engineering performance test, sterility, electromagnetic compatibility, software validation and biocompatibility assessment, as well as the information provided. A new device cannot be marketed unless substantially equivalent by the FDA.
The 510K application entered into force with the establishment registration and device list regulation for 21 CFR 807 manufacturers and the first importers of devices. This regulation places the responsibility for introducing a device to the US market to the following.
With the experience gained over many years, our organization also provides FDA 510K Protective clothing testing services to the demanding enterprises within the framework of laboratory services of the materials with a trained and expert staff.
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Our organization operates in a nationally and internationally approved, independent and impartial manner, in order to increase the product quality of enterprises and to prevent possible commercial risks in international trade. It provides audit, surveillance, inspection, testing, measurement and analysis services for businesses of all sectors and sizes, evaluates, reports and documents.
