Get the free 510(k) Summary of Safety and Effectiveness - accessdata fda

This document presents the summary of safety and effectiveness for the 510(k) premarket notification of the dental product 'Elegant', a porcelain powder for clinical use, including its classifications

How to fill out 510k summary of safety

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

1. Identify the device that requires the 510(k) submission.
2. Gather necessary information about the device, including intended use and technological characteristics.
3. Conduct a substantial equivalence comparison with a predicate device.
4. Summarize the safety and effectiveness data, including non-clinical and clinical testing results.
5. Prepare a table of contents for the summary for easy navigation.
6. Draft a clear and concise executive summary that highlights the key points.
7. Include information about any potential risks and how they are mitigated.
8. Ensure compliance with formatting and submission guidelines outlined by the FDA.
9. Review the summary for accuracy and completeness before submission.
10. Submit the 510(k) along with the summary to the FDA.

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

1. Manufacturers of medical devices that wish to market their products in the U.S.
2. Companies seeking FDA approval for devices that are substantially equivalent to an existing 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 by medical device manufacturers to demonstrate that their device is at least as safe and effective as a device that is already legally marketed in the United States.

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

Medical device manufacturers who intend to market a device that is not exempt from premarket notification requirements under the FDA regulations are required to file a 510(k) Summary of Safety and Effectiveness.

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

To fill out a 510(k) Summary of Safety and Effectiveness, manufacturers must provide specific information about the device, including its intended use, description, labeling, non-clinical and clinical data, and substantial equivalence to a predicate device.

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

The purpose of the 510(k) Summary of Safety and Effectiveness is to allow the FDA to determine whether a medical device is substantially equivalent to an existing legally marketed device, which in turn facilitates the regulatory approval process for the device to be marketed.

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

The information that must be reported includes the device name, applicant details, a description of the device, intended use, technological characteristics, performance testing results, and any relevant labeling information.