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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM. 510(k) Number: K172286 B. Purpose for Submission: To expand the use of previously cleared assay reagents for Factor V Leiden, Coagulation Factor

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Step 1: Begin by obtaining a copy of the current 510(k) Substantial Equivalence Determination form.
2. Step 2: Read the instructions provided on the form carefully to ensure understanding of the requirements and associated documentation.
3. Step 3: Gather all relevant scientific, technical, and clinical data that demonstrates the substantial equivalence of the new device to a legally marketed predicate.
4. Step 4: Fill out the form accurately, providing complete and detailed information in each section.
5. Step 5: Attach all supporting documentation, including test reports, product specifications, labeling information, and any other relevant data.
6. Step 6: Review the completed form and attached documentation to ensure everything is in order and meets the required criteria.
7. Step 7: Submit the filled-out form and supporting documentation to the appropriate regulatory authority, such as the US Food and Drug Administration (FDA).
8. Step 8: Wait for a response from the regulatory authority regarding the acceptance and review of the submission.
9. Step 9: Address any additional requests for information or clarification from the regulatory authority promptly and thoroughly.
10. Step 10: Follow up on the status of the submission and provide any further required documentation or modifications as necessary.
11. Step 11: Once the 510(k) Substantial Equivalence Determination is granted, adhere to any post-market surveillance requirements or reporting obligations.
12. Step 12: Keep a record of the entire process, including all communication, to ensure compliance and facilitate future reference.

Who needs 510k substantial equivalence determination?

1. Any medical device manufacturer planning to introduce a new medical device into the market that is not exempt from the 510(k) requirements.
2. Any medical device manufacturer seeking marketing clearance for a modified medical device that significantly affects its safety or effectiveness.
3. Any medical device manufacturer looking for regulatory approval to commercialize a medical device that is similar in intended use and technological characteristics to a legally marketed device.

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What is 510k substantial equivalence determination?

The 510k substantial equivalence determination is a premarket submission made to the FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is already legally marketed.

Who is required to file 510k substantial equivalence determination?

Any manufacturer who wants to introduce a new medical device to the market that is not exempt from the 510k requirements must file a 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, the manufacturer must provide information about the new device, its intended use, performance data, and how it is similar to a predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to demonstrate that the new device is as safe and effective as a legally marketed predicate device, thereby allowing it to be marketed without the need for extensive clinical trials.

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

The information that must be reported on a 510k substantial equivalence determination includes device descriptions, materials used, performance data, labeling, and any differences between the new device and the predicate device.