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This document provides a summary of safety and effectiveness for the VisionScope High Definition Endoscopy Camera System as per the requirements of the Safe Medical Devices Act and FDA regulations.

How to fill out 510k summary of safety

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

1. Identify the device: Clearly define the medical device that is subject to the 510(k) submission.
2. Gather device information: Collect all relevant data about the device, including its intended use and technological characteristics.
3. Determine substantial equivalence: Compare your device to a predicate device that is already on the market and provide evidence that they are substantially equivalent.
4. Summarize safety and effectiveness: Clearly articulate the safety and effectiveness of your device based on the data collected, including clinical studies if applicable.
5. Include labeling information: Provide details about the proposed labeling for the device, including indications for use, contraindications, warnings, and instructions for use.
6. Format the document: Follow the FDA requirements for formatting the 510(k) summary, ensuring clarity and organization of information.
7. Review and revise: Utilize feedback from colleagues or regulatory experts to refine the summary before submission.
8. Submit the summary: Include the completed 510(k) summary along with the other required documentation in your submission to the FDA.

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

1. Manufacturers of medical devices that are new or modifications of existing devices and are intended for commercial distribution in the U.S.
2. Companies seeking to market devices that require premarket notification under the 510(k) pathway to demonstrate substantial equivalence to a predicate 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 that provides evidence that a medical device is safe and effective for its intended use, and it demonstrates that the device is substantially equivalent to a legally marketed predicate device.

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

Manufacturers of medical devices that are seeking premarket clearance must file a 510(k) Summary of Safety and Effectiveness, especially if their device is not exempt from premarket notification requirements.

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

To fill out the 510(k) Summary of Safety and Effectiveness, manufacturers need to provide detailed information about the device, including its description, intended use, technological characteristics, and performance data, among other requirements as outlined by the FDA.

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 ensure that medical devices marketed in the U.S. are safe and effective, and to facilitate the review process by the FDA for devices that claim equivalence to existing products.

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

The 510(k) Summary of Safety and Effectiveness must include information such as device name, indications for use, a description of the device, comparisons to predicate devices, labeling, and any clinical or non-clinical performance data relevant to safety and effectiveness.