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This document provides a summary of the safety and effectiveness of the flexible video cystoscope/choledochoscope intended for use in urology and surgery, detailing its technological characteristics,

How to fill out 510k summary of safety

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

1. Read the FDA's guidance document on 510(k) submissions to understand the requirements.
2. Identify the device's intended use and technological characteristics.
3. Gather data from tests, studies, and literature that support the safety and effectiveness of the device.
4. Summarize clinical data, non-clinical data, and any other relevant information in a clear and concise manner.
5. Clearly compare the device with a legally marketed equivalent device (predicate device) in terms of intended use and safety/effectiveness.
6. Ensure all necessary forms and documentation are included with the summary, such as labeling information.
7. Review the summary for completeness and accuracy before submission.

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

1. Manufacturers of medical devices seeking to market their products in the U.S.
2. Companies planning to modify an existing medical device that requires evaluation for safety and effectiveness.
3. Importers and distributors looking to ensure compliance with FDA regulations for 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 outlines the safety and effectiveness of a medical device, demonstrating that it is substantially equivalent to a legally marketed device.

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

Manufacturers of medical devices that are intended for commercial distribution in the U.S. and that require premarket notification 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), manufacturers must provide detailed information including device description, intended use, technological characteristics, comparison to a predicate device, and any clinical and non-clinical data supporting the claims of safety and effectiveness.

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

The purpose of the 510(k) Summary is to demonstrate that the device is safe and effective for its intended use and to ensure that it meets applicable regulatory requirements before it can be marketed.

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

The report must include the device's name, intended use, classification, labeling, a description of the device, and evidence supporting its safety and effectiveness including any clinical data and information regarding predicate devices.