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A device may be exempt from 510(k) requirements if the FDA determines that a 510(k) is not required to provide reasonable assurance of safety and effectiveness for the device (see sections 510(l) and 510(m) of the Federal Food, Drug, and Cosmetic (FDC) Act).
What is a 510 K submission?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FDC Act).
What does it mean to be 510 K exempt?
What does it mean to be 510(k) exempt? Some medical devices are not required to undergo the traditional 510(k) submission process to obtain clearance from the FDA before marketing in the US.
What is included in a 510 K submission?
The documentation must include drawings, schematics, and a description of the devices intended use and performance. Selection of the most appropriate predicate device The 510(k) submission must include a comparison of the device under consideration to a predicate device already on the market.
What is 510 K clearance from the US Food and Drug Administration FDA?
The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).
Related Searches
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What is the difference between 510K and FDA approval?
When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.
How do I find my FDA product code?
The easiest way to determine the product code is to become familiar with the product itself, including the label, the processing information, intended use of product, the container type, who will use or consume the product, etc.
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