Get the free Special 510(k) Device Modification OIR Decision ... - FDA

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM ASSAY AND INSTRUMENT COMBINATION TEMPLATE A. 510(k) Number: k141036 B. Purpose for Submission: New Device C. Measured: Capillary whole

How to fill out special 510k device modification

How to fill out special 510k device modification

1. To fill out a special 510k device modification, follow these steps:
2. Gather all necessary information about the modified device, including its intended use, technical specifications, and any changes made.
3. Prepare a detailed cover letter that explains the purpose of the modification and provides a clear description of the changes made.
4. Complete the appropriate sections of the FDA Form 510(k) for a special device modification, including information about the original clearance or approval, the modified device's characteristics, and the reason for the change.
5. Include any additional supporting documentation, such as test reports, risk assessments, or clinical data, that demonstrate the safety and effectiveness of the modified device.
6. Submit the completed form, cover letter, and supporting documentation to the FDA, either electronically through the FDA's Electronic Submissions Gateway (ESG) or by mail.
7. Monitor the status of your submission through the FDA's online tracking system, and respond promptly to any requests for additional information or clarification.
8. Await a decision from the FDA, which will determine whether the modified device is able to maintain its original clearance or approval status, or if additional review is necessary.

Who needs special 510k device modification?

1. Special 510k device modification is needed by manufacturers who have made significant changes to an existing device that has already received FDA clearance or approval.
2. These modifications may include changes to the intended use, design, materials, performance specifications, or labeling of the device.
3. Manufacturers must submit a special 510k device modification to the FDA to demonstrate that the changes do not adversely affect the safety or effectiveness of the device.
4. It is important for manufacturers to consult with the FDA and understand the specific requirements and guidelines for submitting a special 510k device modification for their particular device.

For pdfFiller’s FAQs

Can I create an electronic signature for signing my special 510k device modification in Gmail?

You can easily create your eSignature with pdfFiller and then eSign your special 510k device modification directly from your inbox with the help of pdfFiller’s add-on for Gmail. Please note that you must register for an account in order to save your signatures and signed documents.

How do I edit special 510k device modification on an iOS device?

Create, modify, and share special 510k device modification using the pdfFiller iOS app. Easy to install from the Apple Store. You may sign up for a free trial and then purchase a membership.

How can I fill out special 510k device modification on an iOS device?

pdfFiller has an iOS app that lets you fill out documents on your phone. A subscription to the service means you can make an account or log in to one you already have. As soon as the registration process is done, upload your special 510k device modification. You can now use pdfFiller's more advanced features, like adding fillable fields and eSigning documents, as well as accessing them from any device, no matter where you are in the world.

What is special 510k device modification?

A Special 510(k) device modification is a streamlined process for certain modifications to medical devices that have already been cleared through the 510(k) process. It allows manufacturers to demonstrate that the changes do not significantly affect the device's safety or effectiveness.

Who is required to file special 510k device modification?

Manufacturers of medical devices who make modifications to an already cleared device and believe these modifications do not substantially change its intended use or significantly affect its safety or effectiveness are required to file a Special 510(k).

How to fill out special 510k device modification?

To fill out a Special 510(k) submission, manufacturers must complete the 510(k) form, providing detailed information about the device and the modifications made, including a summary of the changes, any supporting data, labeling, and any relevant tests or analyses that demonstrate compliance.

What is the purpose of special 510k device modification?

The purpose of the Special 510(k) device modification is to provide a more efficient and timely means for manufacturers to obtain FDA clearance for certain modifications to existing devices, thereby promoting innovation while maintaining safety and effectiveness standards.

What information must be reported on special 510k device modification?

The information that must be reported includes a description of the device and its intended use, a detailed description of the modifications, a summary of any performance testing or other data supporting the modifications, labeling changes, and any previous 510(k) numbers if applicable.