Get the free Exhibit #2 510(k) Summary - accessdata fda

This document is a 510(k) summary submitted for the Locking Bone Screw, detailing its safety and effectiveness, intended use, device classification, and regulatory compliance based on established

How to fill out exhibit 2 510k summary

How to fill out Exhibit #2 510(k) Summary

1. Begin by gathering necessary product information including device name, manufacturer details, and intended use.
2. Identify the predicate device and collect its 510(k) number.
3. Describe the device including its design, materials, and technology components.
4. Outline the indications for use and how they relate to the predicate device.
5. Provide performance data, including bench testing results, if applicable.
6. Summarize any clinical data that supports your device's safety and effectiveness.
7. Include any relevant labeling information and proposed package insert.
8. Review the completed summary to ensure all required fields are accurately filled in.
9. Submit the Exhibit #2 510(k) Summary along with your 510(k) application.

Who needs Exhibit #2 510(k) Summary?

1. All manufacturers of medical devices seeking FDA clearance for a new device that is substantially equivalent to an already marketed device.
2. Companies looking to provide safety and effectiveness evidence to obtain FDA marketing authorization.

People Also Ask about

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 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).

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 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 does it take to get a 510 K approval?

The FDA has 90 days to review a traditional 510(k), but the timeline can vary from three to eight months depending on additional information requests and other factors.

Do class II devices require 510k?

510(k) Exemptions Most class I and some class II devices are exempt from 510(k) requirements, subject to certain limitations (see section 510(l)(1) of the Federal Food, Drug, and Cosmetic Act).

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.

For pdfFiller’s FAQs

What is Exhibit #2 510(k) Summary?

Exhibit #2 510(k) Summary is a document submitted to the FDA as part of the 510(k) premarket notification process. It provides a detailed description of the device, its intended use, and its safety and efficacy based on comparison with a predicate device.

Who is required to file Exhibit #2 510(k) Summary?

Manufacturers of medical devices who wish to market their devices in the U.S. and have determined that their device is substantially equivalent to a predicate device must file Exhibit #2 510(k) Summary.

How to fill out Exhibit #2 510(k) Summary?

To fill out Exhibit #2 510(k) Summary, manufacturers must provide specific information including device identification, intended use, description of the device, labeling, performance testing data, and a summary of any comparisons made to the predicate device.

What is the purpose of Exhibit #2 510(k) Summary?

The purpose of Exhibit #2 510(k) Summary is to demonstrate to the FDA that the new device is safe and effective, and substantially equivalent to a legally marketed device, thereby facilitating the regulatory review process.

What information must be reported on Exhibit #2 510(k) Summary?

The information that must be reported on Exhibit #2 510(k) Summary includes the device name, manufacturer details, proposed indications for use, device description, comparison to predicate devices, summary of performance testing, and relevant labeling information.