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This document provides a comprehensive summary of the safety and effectiveness of the Future Wash and YPS dental impression materials, including details about their classifications, predicate devices,

How to fill out 510k summary of safety

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

1. Title: Provide a clear title that includes the device name and description.
2. Submitter Information: Include the name, address, and contact details of the company submitting the 510(k).
3. Device Description: Describe the device, including intended use, technology, and materials.
4. Predicate Device: Identify the legally marketed device to which you are claiming substantial equivalence.
5. Comparison: Provide a summary of similarities and differences between your device and the predicate device.
6. Indications for Use: State the intended use and indications for the device.
7. Summary of Safety and Effectiveness: Present data supporting the safety and effectiveness of the device, including clinical data if applicable.
8. Conclusions: Summarize the rationale for why the device is considered safe and effective.
9. Supporting Documents: Include references, testing reports, and any other relevant documents.
10. Certification Statement: Add a statement certifying that the summary is true and acknowledges FDA regulations.

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

1. Manufacturers of medical devices that require premarket notification to the FDA.
2. Companies seeking to market devices that are substantially equivalent to existing (predicate) devices.
3. Those involved in the development, regulatory compliance, and marketing of medical devices.

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 includes information about a medical device's safety and effectiveness. It is required for devices that are being cleared for market through the 510(k) premarket notification process.

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

Manufacturers of medical devices that are classified as moderate risk and wish to market their devices in the United States are required to file a 510(k) Summary of Safety and Effectiveness with the FDA.

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

To fill out a 510(k) Summary, follow the FDA guidelines and provide detailed information about the device, including its specifications, intended use, labeling, and any clinical data supporting its safety and effectiveness. It should also include comparisons 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 demonstrate to the FDA that a new medical device is substantially equivalent to an existing, legally marketed device and that it is safe and effective for its intended use.

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

The 510(k) Summary must report information such as device name, applicant information, device description, intended use, technological characteristics, performance data, and labeling information, as well as any comparisons to predicate devices.