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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE A. 510(k) Number: k060434 B. Purpose for Submission: Notification of intent to manufacture and market new device C.

How to fill out 510k substantial equivalence determination

1. Completing the 510k substantial equivalence determination involves the following steps:
2. The 510k substantial equivalence determination is required for medical device manufacturers seeking to market their devices in the United States. Any company or individual that wishes to introduce a new medical device or significantly modify an existing one must submit a 510k premarket notification to the Food and Drug Administration (FDA). This notification includes the substantial equivalence determination, which demonstrates that the new or modified device is as safe and effective as a legally marketed predicate device. Therefore, any medical device manufacturer intending to market their product in the US needs to go through the process of 510k substantial equivalence determination.

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What is 510k substantial equivalence determination?

The 510k substantial equivalence determination is a process conducted by the U.S. Food and Drug Administration (FDA) to determine whether a new medical device is substantially equivalent to a legally marketed device, known as a predicate device, that does not require premarket approval.

Who is required to file 510k substantial equivalence determination?

Any person or organization who intends to market a new medical device in the United States is required to file a 510k substantial equivalence determination with the FDA.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, the applicant needs to provide detailed information about the new device, compare it to the predicate device, and address any differences, including performance, design, materials, and intended use. The FDA provides specific guidelines and forms to assist with the submission process.

What is the purpose of 510k substantial equivalence determination?

The purpose of the 510k substantial equivalence determination is to demonstrate that the new medical device is as safe and effective as the predicate device and does not pose any additional risks to patients or users. It helps ensure that new devices undergo proper assessment before being marketed.

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

The 510k substantial equivalence determination requires detailed information about the new device, including its intended use, indications for use, technological characteristics, performance data, labeling, and any potential adverse effects or risks associated with its use.