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

This document summarizes the safety and effectiveness of the CoSP2 retraction paste and its comparison with predicate devices. It includes details on device intent, manufacturer information, and FDA

How to fill out 510k summary of safety

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

1. Gather information about the medical device, including its intended use and technological characteristics.
2. Identify the predicate device that your device is being compared to.
3. Create a detailed description of the device, including design, components, and specifications.
4. Conduct and document safety and effectiveness testing, including clinical data if applicable.
5. Compile a comparison table that demonstrates similarities and differences between your device and the predicate device.
6. Draft the summary section, providing a concise overview of the device's safety and effectiveness.
7. Include any relevant labeling information, such as instructions for use and contraindications.
8. Review the summary for completeness and accuracy, ensuring all required elements are included.
9. Submit the 510(k) summary as part of the overall premarket submission to the FDA.

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

1. Manufacturers of medical devices that must demonstrate substantial equivalence to a legally marketed predicate device must prepare a 510(k) Summary of Safety and Effectiveness.
2. Companies marketing new devices that are not exempt from premarket notification requirements.
3. Developers seeking FDA clearance for modifications to existing devices that may impact safety or effectiveness.

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 a legally marketed device. It includes information about the device's intended use, technology, labeling, and safety and effectiveness data.

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

Manufacturers of medical devices that intend to market devices in the United States and who are seeking clearance for devices that are not exempt from premarket notification requirements must submit a 510(k) Summary.

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

To fill out a 510(k) Summary, a manufacturer must provide specific information about their device, including its name, description, intended use, technological characteristics, performance testing data, and how it compares to predicate devices. Templates and guidance documents provided by the FDA can be used to ensure compliance.

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

The purpose of the 510(k) Summary is to inform the FDA about the device's safety and effectiveness, demonstrating that it is substantially equivalent to an already marketed device. This process helps ensure that new medical devices meet regulatory requirements before reaching the market.

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

The 510(k) Summary must report information including the device name, manufacturer details, a description of the device, its intended use, technological characteristics, any performance testing results, labeling, and comparisons with predicate devices.