Get the free 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION CHECKLIST

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k160944 B. Purpose for Submission: New device C. Measured: Capillary whole

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination:

1. Begin by referencing the Code of Federal Regulations (CFR) 21 Part 807 Subpart E to gather information on the required content and format of the 510k submission.
2. Provide the necessary administrative information, such as your company name, product trade name, and contact details. Include any previous 510k numbers or related submissions if applicable.
3. Clearly identify the predicate device(s) and describe the similarities and differences between your device and the predicate(s). Include detailed technical specifications, such as materials, design features, and intended use.
4. Conduct a comprehensive risk assessment of your device and compare it to the predicate device(s). Provide detailed information on any potential risks, mitigations, and labeling instructions to address those risks.
5. Include a detailed description of any performance or clinical testing you have conducted on your device. Provide test protocols, results, and analysis to demonstrate substantial equivalence to the predicate(s).
6. If your device utilizes software or electronic interfaces, outline the design, functionality, and validation of the software system. Include any software documentation, test/validation reports, and relevant standards compliance.
7. Prepare a comprehensive labeling section that includes all instructions for use, warnings, precautions, and contraindications. Ensure that all labeling meets the labeling requirements outlined in CFR 21 Part 801.
8. Compile a comprehensive summary of the supporting data, including any published literature, clinical studies, or post-market surveillance information that supports the substantial equivalence determination.
9. Complete all required forms and attachments, such as the FDA Form 3514 or the Bioresearch Monitoring Information System (BMIS) cover sheet.

Who needs 510k substantial equivalence determination:

1. Medical device manufacturers intending to market a new device that is not exempt from 510k submission regulations.
2. Manufacturers seeking to introduce modifications to an existing device that may significantly affect its safety or effectiveness.
3. Companies introducing a device that relies on a different technological principle compared to the predicate device.
4. Manufacturers seeking marketing clearance for replacement parts or components of a legally marketed device that do not meet the criteria for a "class I" or "class II" exemption.
5. International manufacturers intending to market a device in the United States for the first time.

It is essential to consult the FDA's current guidance documents and seek professional advice to ensure compliance and accuracy when filling out the 510k substantial equivalence determination.

For pdfFiller’s FAQs

How can I modify 510k substantial equivalence determination without leaving Google Drive?

You can quickly improve your document management and form preparation by integrating pdfFiller with Google Docs so that you can create, edit and sign documents directly from your Google Drive. The add-on enables you to transform your 510k substantial equivalence determination into a dynamic fillable form that you can manage and eSign from any internet-connected device.

Where do I find 510k substantial equivalence determination?

The pdfFiller premium subscription gives you access to a large library of fillable forms (over 25 million fillable templates) that you can download, fill out, print, and sign. In the library, you'll have no problem discovering state-specific 510k substantial equivalence determination and other forms. Find the template you want and tweak it with powerful editing tools.

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

Get and install the pdfFiller application for iOS. Next, open the app and log in or create an account to get access to all of the solution’s editing features. To open your 510k substantial equivalence determination, upload it from your device or cloud storage, or enter the document URL. After you complete all of the required fields within the document and eSign it (if that is needed), you can save it or share it with others.

What is 510k substantial equivalence determination?

This determination is a pre-market submission made to FDA to demonstrate that a new medical device is substantially equivalent to a predicate device that is legally marketed.

Who is required to file 510k substantial equivalence determination?

Any manufacturer intending to market a new medical device in the U.S. is required to file a 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

The manufacturer needs to provide information on the new device and compare it to a predicate device, demonstrating that they are substantially equivalent in terms of safety and efficacy.

What is the purpose of 510k substantial equivalence determination?

The purpose is to show that the new device is as safe and effective as a legally marketed device, thus allowing its marketing in the U.S. without the need for clinical testing.

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

The submission must include device description, intended use, technical specifications, comparison to predicate device, and any performance data or testing results.