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Frequently Asked Questions

When to submit a new 510(k)?

After May 28, 1976 (effective date of the Medical Device Amendments to the Act), anyone who wants to sell a device in the U.S. is required to make a 510 (k) submission at least 90 days prior to offering the device for sale, even though it may have been under development or clinical investigation before that date.

When is a 510(k) needed?

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.

Do I need to submit a new 510(k)?

If use of either guidance leads to a "new 510 (k)" conclusion, submission of a new 510 (k) is likely required. Examples of software modifications that may require a new 510 (k) include, but are not limited to, the following: A change that introduces a new risk or modifies an existing risk that could result in significant harm

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