Keyword Analysis & Research: 510k fda guidance

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When to submit a 510 k guidance?

The Traditional 510 (k) Program can be used under any circumstance to seek marketing authorization of a device through the 510 (k) Program. There is no Premarket Notification 510 (k) "form" to complete. A 510 (k) is a submission containing information required under 21 CFR 807.87.

Who is required by the FDA to file a 510k?

The FD&C Act and the 510 (k) regulation (21 CFR 807) do not specify who must submit a 510 (k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510...

Who is required to submit a 510k?

510(k) Definition. Section 510(k) of the FD&C Act (amended on May 28, 1976, to include medical devices) requires device manufacturers who must register to submit a premarket notification (PMN) to the FDA, informing them of their intent to market a medical device at least 90 days in advance.

When do you need a 510k?

Repackers or relabelers who make labeling changes or whose operations significantly affect the device. Repackagers or relabelers may be required to submit a 510 (k) if they significantly change the labeling or otherwise affect any condition of the device.

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