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This document provides a summary of the safety and effectiveness of the Hermes Bond dental adhesive, including details on its chemical composition, intended use, and comparison with predicate devices.

How to fill out 510k summary of safety

How to fill out 510(k) Summary of Safety and Effectiveness

1. Identify the device and its intended use.
2. Gather information on the device's design and manufacturing processes.
3. Compile safety and effectiveness data, including results from clinical studies, if applicable.
4. Evaluate and summarize any potential risks and benefits associated with the device.
5. Include a comparison with a legally marketed predicate device, outlining similarities and differences.
6. Prepare a summary of the device's performance testing, including bench testing and, if necessary, clinical evaluation.
7. Ensure all required documentation is complete and complies with FDA regulations.
8. Submit the completed 510(k) Summary to the FDA for review.

Who needs 510(k) Summary of Safety and Effectiveness?

1. Manufacturers of medical devices that are seeking marketing clearance in the United States.
2. Companies that wish to demonstrate that their device is substantially equivalent to a legally marketed predicate device.
3. Importers and distributors of medical devices intending to sell or market the device.

People Also Ask about

What is the 501k process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the rejection rate for 510k?

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 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.

How long does FDA 510 K approval take?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

What are the three types of 510k?

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements.

How long does 501k approval take?

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.

Is 510k safe and effective?

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).

For pdfFiller’s FAQs

What is 510(k) Summary of Safety and Effectiveness?

The 510(k) Summary of Safety and Effectiveness is a document submitted to the FDA that provides information demonstrating that a medical device is safe and effective for its intended use, based on a comparison to a legally marketed device.

Who is required to file 510(k) Summary of Safety and Effectiveness?

Manufacturers of certain medical devices that are not exempt from premarket notification are required to file a 510(k) Summary of Safety and Effectiveness with the FDA before marketing their device.

How to fill out 510(k) Summary of Safety and Effectiveness?

To fill out the 510(k) Summary, applicants must provide details such as the device's name, intended use, description, substantial equivalence to existing devices, and data supporting safety and effectiveness.

What is the purpose of 510(k) Summary of Safety and Effectiveness?

The purpose of the 510(k) Summary is to ensure that new medical devices are shown to be substantially equivalent to existing devices, thereby ensuring their safety and effectiveness before they reach the market.

What information must be reported on 510(k) Summary of Safety and Effectiveness?

The 510(k) Summary must report information such as the device's name, intended use, description, manufacturing information, design specifications, labeling, and any performance testing data that supports safety and effectiveness.