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This document outlines the safety and effectiveness of the Carbon Fiber Bridge, a dental device intended for use as a denture base material to restore chewing function in edentulous patients.

How to fill out 51ok summary of safety

How to fill out 51O(k) Summary of Safety and Effectiveness

1. Gather all relevant data regarding the device's safety and effectiveness.
2. Review the submission requirements specified by the FDA for a 510(k) application.
3. Complete the detailed device description section, including indications for use.
4. Identify and compare the device to a predicate device that is already cleared by the FDA.
5. Compile non-clinical and clinical data that supports the device's safety and effectiveness.
6. Prepare summaries of any testing conducted, including performance and biocompatibility testing.
7. Include labeling information that complies with FDA requirements.
8. Have all sections reviewed for clarity and completeness before final submission.
9. Submit the 510(k) application electronically via the FDA's submission system.
10. Respond promptly to any inquiries or requests for additional information from the FDA.

Who needs 51O(k) Summary of Safety and Effectiveness?

1. Manufacturers of medical devices that are seeking FDA clearance for new devices.
2. Companies that intend to make modifications to existing devices that could affect safety or effectiveness.
3. Entities looking to market devices that are substantially equivalent to a legally marketed predicate device.

People Also Ask about

What is the 510k summary?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What is 510k summary report?

A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.

What is the 501k process?

The SSED is an FDA document intended to present a reasoned, objective, and balanced summary of the scientific evidence, both positive and negative, that served as the basis of the decision to approve or deny the PMA.

What is the summary of safety and effectiveness data FDA?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

What is the FDA 510k summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

How long does 501k approval take?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

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What is 51O(k) Summary of Safety and Effectiveness?

The 510(k) Summary of Safety and Effectiveness is a document submitted to the FDA that outlines the safety and effectiveness of a medical device, demonstrating its substantial equivalence to a legally marketed device.

Who is required to file 51O(k) Summary of Safety and Effectiveness?

Manufacturers of medical devices seeking to market a new device that is not significantly different from an existing device must file a 510(k) Summary of Safety and Effectiveness with the FDA.

How to fill out 51O(k) Summary of Safety and Effectiveness?

To fill out a 510(k) Summary, manufacturers need to provide detailed information about the device, including its description, intended use, technological characteristics, and performance data, demonstrating substantial equivalence.

What is the purpose of 51O(k) Summary of Safety and Effectiveness?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the device is safe and effective, and whether it is substantially equivalent to a predicate device.

What information must be reported on 51O(k) Summary of Safety and Effectiveness?

The information that must be reported includes the manufacturer's information, device description, intended use, technological characteristics, performance testing results, and labeling information.