Get the free 510(k) Substantial Equivalence Determination Decision Memorandum Assay and Instrumen...

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k182549 B. Purpose for Submission: This submission is a Dual 510(k) and CIA

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. Begin by collecting all necessary information about the device you wish to compare to the predicate device.
2. Prepare a detailed summary of the device, including its intended use, technical specifications, and any clinical or performance test data.
3. Identify the predicate device that you believe to be substantially equivalent to your device. Make sure to gather all relevant information about the predicate device.
4. Conduct a thorough comparison between your device and the predicate device, taking into account their intended use, technological characteristics, and performance.
5. Document your findings in a substantial equivalence determination report, clearly stating the similarities and differences between your device and the predicate device.
6. Include any additional information or data that supports your claim of substantial equivalence.
7. Review and revise your report to ensure it is well-organized, informative, and persuasive.
8. Submit your substantial equivalence determination report, along with the required forms and fees, to the appropriate regulatory authority for evaluation.
9. Provide the regulatory authority with any requested additional information or clarification throughout the review process.
10. Await the determination from the regulatory authority regarding the substantial equivalence of your device.

Who needs 510k substantial equivalence determination?

1. Any medical device manufacturer or distributor that wishes to market a new device in the United States may need to obtain a 510k substantial equivalence determination.
2. This requirement applies to devices that are not already classified as exempt from premarket notification requirements by the regulatory authority.
3. It is important to consult with the regulatory authority and determine whether a 510k determination is necessary for your specific device.

For pdfFiller’s FAQs

How do I fill out the 510k substantial equivalence determination form on my smartphone?

Use the pdfFiller mobile app to fill out and sign 510k substantial equivalence determination on your phone or tablet. Visit our website to learn more about our mobile apps, how they work, and how to get started.

How do I complete 510k substantial equivalence determination on an iOS device?

In order to fill out documents on your iOS device, install the pdfFiller app. Create an account or log in to an existing one if you have a subscription to the service. Once the registration process is complete, upload your 510k substantial equivalence determination. You now can take advantage of pdfFiller's advanced functionalities: adding fillable fields and eSigning documents, and accessing them from any device, wherever you are.

How do I edit 510k substantial equivalence determination on an Android device?

Yes, you can. With the pdfFiller mobile app for Android, you can edit, sign, and share 510k substantial equivalence determination on your mobile device from any location; only an internet connection is needed. Get the app and start to streamline your document workflow from anywhere.

What is 510k substantial equivalence determination?

The 510(k) substantial equivalence determination is a premarket submission made to FDA to demonstrate that a new medical device is substantially equivalent to a predicate device.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices seeking FDA approval 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 need to provide information on the new device's intended use, technological characteristics, and any differences from the predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of a 510(k) substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed device (predicate) and does not raise new questions of safety and effectiveness.

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

Information required on a 510(k) substantial equivalence determination includes device description, intended use, technological characteristics, performance data, risk analysis, and labeling.