Get the free Section 6 - 510(k) Summary - accessdata fda

This document summarizes safety and effectiveness information for the dental product MI Varnish, submitted in accordance with FDA regulations for medical devices.

How to fill out section 6 - 510k

How to fill out Section 6 - 510(k) Summary

1. Begin by gathering all required information about your device.
2. Clearly state the identity of the device, including its trade name and common name.
3. Describe the intended use of the device and the indications for use.
4. Provide a summary of the technological characteristics of the device.
5. Include information on any previous 510(k) submissions for the device or similar devices.
6. Summarize the differences between your device and the predicate devices.
7. Present the safety and effectiveness data, including any clinical studies if applicable.
8. Ensure compliance with all applicable regulations and guidelines.
9. Review your summary for clarity and completeness before submission.

Who needs Section 6 - 510(k) Summary?

1. Manufacturers of medical devices seeking to market their products in the United States.
2. Companies that are submitting a premarket notification (510(k)) to demonstrate that their device is substantially equivalent to a legally marketed device.
3. Regulatory Affairs professionals involved in the preparation of 510(k) submissions.

People Also Ask about

What are the three types of 510k?

If so, then the 510(k) pathway is not appropriate, and instead, a De Novo or PMA is needed. There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices.

What is the difference between 510k and FDA approval?

The purpose of a 510(k) submission is to prove that your device is safe and effective by comparing it to a similar, legally marketed device—what the FDA calls a “predicate device.” If your 510(k) submission is approved, your product has earned FDA clearance, and you can legally market it.

What does FDA granted 510 K clearance mean?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

How to prepare a 510 K submission?

1. Preparing for the submission process Identifying a predicate device. Special controls, guidance, and software considerations. Clinical data inclusion. Pre-Submission (or Q-submission) Demonstrating substantial equivalence. Writing a clear and compelling submission. Interpreting the FDA's feedback.

What is the content of 510k summary?

The 510(k) Statement is a certification that the 510(k) owner will provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request.

What is the truthful and accurate statement FDA?

Section 6.0 – Truthful and Accuracy Statement is exactly what it sounds like. It's a statement that certifies that all of the information included is truthful and accurate and that nothing has been omitted. To make it even easier for you, the FDA has provided you with the exact content of the statement.

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

For pdfFiller’s FAQs

What is Section 6 - 510(k) Summary?

Section 6 - 510(k) Summary is a document that provides detailed information about a medical device that is submitted to the FDA to demonstrate that the device is safe and effective for its intended use.

Who is required to file Section 6 - 510(k) Summary?

Manufacturers or distributors of medical devices that intend to market their products in the United States are required to file a Section 6 - 510(k) Summary with the FDA.

How to fill out Section 6 - 510(k) Summary?

To fill out Section 6 - 510(k) Summary, manufacturers should follow the FDA guidelines, providing detailed descriptions of the device, its intended use, technological characteristics, and comparisons to predicate devices.

What is the purpose of Section 6 - 510(k) Summary?

The purpose of Section 6 - 510(k) Summary is to provide the FDA and the public with essential information about the device's safety and efficacy in relation to existing products.

What information must be reported on Section 6 - 510(k) Summary?

The information that must be reported includes device identification, intended use, description of the device, performance testing data, and comparison with the predicate device.