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

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY. 510(k) Number: K173840 B. Purpose for Submission: To change a limitation statement pertaining to pregnant women in the Cepheid Expert

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination:

1. Start by gathering all the necessary information and documentation required for the submission.
2. Review the relevant FDA guidance documents and regulations to ensure you understand the requirements for the determination.
3. Begin completing the 510k application form, providing accurate and detailed information about the device in question.
4. Clearly describe the intended use and indications for use of the device.
5. Include information about the device design, composition, materials, and components.
6. Provide a detailed description of the device's technological characteristics and performance specifications.
7. Include any applicable labeling, including instructions for use and warnings.
8. If applicable, provide information on any preclinical testing, clinical studies, or performance data that demonstrate the device's safety and effectiveness.
9. Address any differences or modifications between the new device and the predicate device(s) being compared for substantial equivalence.
10. Submit the completed 510k substantial equivalence determination to the FDA for review and approval.

Who needs 510k substantial equivalence determination:

1. Medical device manufacturers who intend to market a new device that is not exempt from the 510k requirements need to go through the substantial equivalence determination process.
2. Individuals or companies seeking to introduce a device into the U.S. market that has modifications or differences from a legally marketed predicate device.
3. Manufacturers looking to demonstrate that their new device has the same intended use, technological characteristics, and performance as a previously cleared and legally marketed device.

It is important to remember that the content provided in this answer is for informational purposes only and should not be considered as legal or regulatory advice. It is always recommended to consult with the appropriate regulatory authorities or seek professional guidance when filling out the 510k substantial equivalence determination.

For pdfFiller’s FAQs

How do I edit 510k substantial equivalence determination online?

The editing procedure is simple with pdfFiller. Open your 510k substantial equivalence determination in the editor, which is quite user-friendly. You may use it to blackout, redact, write, and erase text, add photos, draw arrows and lines, set sticky notes and text boxes, and much more.

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

The pdfFiller mobile app makes it simple to design and fill out legal paperwork. Complete and sign 510k substantial equivalence determination and other papers using the app. Visit pdfFiller's website to learn more about the PDF editor's features.

How can I fill out 510k substantial equivalence determination on an iOS device?

Make sure you get and install the pdfFiller iOS app. Next, open the app and log in or set up an account to use all of the solution's editing tools. If you want to open your 510k substantial equivalence determination, you can upload it from your device or cloud storage, or you can type the document's URL into the box on the right. After you fill in all of the required fields in the document and eSign it, if that is required, you can save or share it with other people.

What is 510k substantial equivalence determination?

510k substantial equivalence determination is a process by which medical device manufacturers demonstrate that a new device is at least as safe and effective as a legally marketed device (predicate) that is not subject to PMA.

Who is required to file 510k substantial equivalence determination?

Medical device manufacturers who are introducing a new device to the market are required to file 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, manufacturers need to provide information on the new device, compare it to a predicate device, and submit evidence supporting the claim of substantial equivalence.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed device, without the need for premarket approval (PMA).

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

Information such as device description, intended use, technological characteristics, performance data, and a comparison to a predicate device must be reported on 510k substantial equivalence determination.