Keyword Analysis & Research: 510k

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Frequently Asked Questions

Who is required to submit a 510k?

The following four categories of parties must submit a 510 (k) to the FDA: Finished device manufacturers must submit a 510 (k) if they manufacture a device according to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices.

When do you need a 510k?

Major modifications to the device likely require premarket review by the FDA, while minor changes likely do not. A premarket notification (510 (k)) is required when a legally marketed device subject to 510 (k) requirements is significantly changed or modified in design, components, method of manufacture, or intended use.

What does 510(k) mean?

This order "clears" the device for commercial distribution (see The 510 (k) Program Guidance ). 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) FD&C Act).

What is a 510k medical device?

What is a 510 (k)? A 510 (k) is the technical dossier required by the US Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. It is formally called a Pre-market Notification. A 510 (k) contains detailed technical, safety, and performance information about a medical device.

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