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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.

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

What is 510 k process?

FDA’s 510(k) pre-market review process for medical devices provides strong protections to American patients and promotes medical innovation. It provides FDA the flexibility it needs to ensure the safety and effectiveness of low- and moderate-risk medical devices whose risks are well-understood from experience with similar devices.

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.


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