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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM. 510(k) Number: K172244 B. Purpose for Submission: New Device on a previously cleared instrument C. Measured: Antidouble stranded DNA

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. To fill out the 510(k) substantial equivalence determination, follow these steps:
2. Gather all necessary information and documents related to your medical device.
3. Identify the predicate device against which you want to claim substantial equivalence.
4. Review the FDA guidance documents and regulations pertaining to substantial equivalence determination.
5. Prepare a detailed comparison between your device and the predicate device, highlighting all similarities and differences.
6. Provide scientific and technical evidence to support your claim of substantial equivalence.
7. Fill out the 510(k) submission form accurately and completely, including all required sections and attachments.
8. Include a cover letter summarizing your submission and explaining the basis for claiming substantial equivalence.
9. Ensure that all supporting documents are properly organized and labeled.
10. Submit the completed 510(k) substantial equivalence determination to the FDA for review.
11. Be prepared to respond to any requests for additional information or clarification from the FDA during the review process.

Who needs 510k substantial equivalence determination?

1. Any manufacturer or distributor of a medical device that is intending to market a new device or a modification of an existing device in the U.S. may need to obtain a 510(k) substantial equivalence determination.
2. This determination is required by the FDA to demonstrate that the new device is as safe and effective as a legally marketed device (predicate device) and does not raise any new safety or effectiveness concerns.
3. Therefore, any individual or company seeking to introduce a medical device into the U.S. market that does not fall under an exemption or special regulatory pathway would need to go through the 510(k) substantial equivalence determination process.

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What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a process by which the FDA evaluates whether a new medical device is substantially equivalent to an existing, legally marketed device, allowing it to be marketed without undergoing the full premarket approval process.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices who intend to market a new device that is claimed to be substantially equivalent to a legally marketed device are required to file a 510(k) substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510(k) substantial equivalence determination, manufacturers must complete the FDA's submission form, providing information about the device, its intended use, technological characteristics, and data demonstrating its substantial equivalence to the predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510(k) substantial equivalence determination is to ensure that new medical devices are safe and effective for their intended use by comparing them to existing devices.

What information must be reported on 510k substantial equivalence determination?

The information required includes the device name, intended use, description of the device, comparison to a predicate device, any supporting data (e.g., performance data, safety information), and labeling information.