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This document provides a summary of the safety and effectiveness of the 0.9% Sodium Chloride Flush Syringe, including regulatory details and indications for use in intravenous treatments.

How to fill out 510k summary of safety

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

1. Identify the device and its intended use.
2. Gather and summarize available safety and effectiveness data.
3. Compare the device to a legally marketed predicate device.
4. Include information about the proposed labeling and instructions for use.
5. Detail any testing conducted (laboratory, clinical, etc.) to support the claims.
6. Provide a risk analysis, outlining potential hazards and mitigations.
7. Ensure all sections are organized and clearly written.
8. Review and comply with FDA formatting and content requirements.

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

1. Manufacturers of medical devices that aim to market a new device that is substantially equivalent to an existing, legally marketed device.
2. Companies introducing modifications to existing devices that significantly change the intended use or technological characteristics.
3. Any entity seeking FDA clearance for devices that are not exempt from 510(k) requirements.

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 information about a medical device and asserts that the device 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 intend to market devices in the United States and claim substantial equivalence to an existing device are required to file a 510(k) Summary.

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

To fill out the 510(k) Summary, manufacturers should gather information about the device, including its intended use, technological characteristics, clinical data, and comparisons to predicate devices, and then complete the specified sections in the FDA's guidance document.

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

The purpose of the 510(k) Summary is to demonstrate to the FDA that a new device is safe and effective for its intended use by establishing substantial equivalence to a previously cleared device.

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

The 510(k) Summary must report information including the device name, intended use, description, summary of technological characteristics, and any performance data or clinical data to support safety and effectiveness claims.