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This document provides a summary of the safety and effectiveness of the Bellus Shading Kit, a device intended for color staining and glazing of glass ceramic restorations. It includes details on regulation,

How to fill out 510k summary of safety

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

1. Identify the device you are submitting a 510(k) for.
2. Gather all relevant scientific data, studies, and product specifications.
3. Prepare a description of the device, including its intended use, components, and the technology it uses.
4. Summarize the safety and effectiveness data, including any relevant clinical data.
5. Compare your device to a legally marketed predicate device, highlighting similarities and differences.
6. Provide a list of indications for use and any potential risks associated with the device.
7. Include any labeling and advertising materials that will accompany the device.
8. Review and finalize the document to ensure accuracy and completeness.
9. Submit the 510(k) Summary of Safety and Effectiveness to the FDA along with the 510(k) application.

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

1. Manufacturers of medical devices seeking FDA clearance to market their products in the United States.
2. Companies developing new medical devices that are substantially equivalent to existing, legally marketed devices.
3. Entities looking to enhance or modify an existing medical 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 substantially equivalent to an already legally marketed device, known as a 'predicate' device. It summarizes the safety and effectiveness information supporting the device's performance.

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

Manufacturers of medical devices that are not exempt from premarket notification requirements under the FDA regulations are required to file a 510(k) Summary of Safety and Effectiveness before they can market their device.

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 details including the device description, intended use, proposed labeling, and comparison to predicate devices, along with safety and effectiveness data that supports their claims.

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 inform the FDA and the public about the safety and effectiveness of a new medical device, ensuring that it meets regulatory standards for market approval.

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

Information required includes the device name, 510(k) number, manufacturer details, intended use, description of the device, performance testing results, and any potential safety concerns related to the device.