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This document is a 510(k) summary for the Aquadex FlexFlow System, outlining the device's intended use, classification, regulatory compliance, and safety information as it pertains to its ultrafiltration

How to fill out 51 0k summary

How to fill out 51 0(k) Summary

1. Start with the basic information: Enter the name of the applicant and the device being summarized.
2. Provide a description of the device: Detail the intended use and the technological characteristics.
3. List the predicate device: Identify the 510(k) device to which you are claiming equivalence.
4. Outline the performance data: Include any non-clinical and clinical data demonstrating safety and effectiveness.
5. Complete the labeling information: Attach proposed labeling, instructions for use, and any promotional materials.
6. Include any additional documentation: Provide any other relevant information or studies that support your submission.

Who needs 51 0(k) Summary?

1. Manufacturers seeking approval for a medical device that is substantially equivalent to an existing device.
2. Companies planning to market a new device that is similar to an already cleared device and requires a 510(k) submission.
3. Developers of medical devices that require FDA review before being sold in the United States.

People Also Ask about

How long does it take to get a 510 K approval?

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.

What is 501k approval?

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 difference between FDA and FDA 510k?

The Primary Difference Between FDA And FDA 510k The main distinction between the FDA vs FDA 510(k) is that the FDA oversees total product safety, whereas FDA 510(k) is a premarket submission procedure for medical device clearance based on equivalence.

How long does 510 K clearance take?

The FDA's 510(k) submission process is, in a nutshell, a clearance process which every company wanting to bring a medium-risk medical device to the American market must pass through. Almost half of all medical devices used in the United States every day will have passed through the 510(k) route.

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.

What is the 510 K process?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the 510k 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

For pdfFiller’s FAQs

What is 51 0(k) Summary?

The 510(k) Summary is a document submitted to the FDA that demonstrates that a medical device is safe and effective, and it is substantially equivalent to an existing legally marketed device.

Who is required to file 51 0(k) Summary?

Manufacturers of medical devices who intend to market a device that is not exempt from premarket notification must file a 510(k) Summary.

How to fill out 51 0(k) Summary?

To fill out a 510(k) Summary, manufacturers must provide information including device description, intended use, technological characteristics, performance data, and compliance with applicable standards.

What is the purpose of 51 0(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether a device is substantially equivalent to a device already on the market and can be marketed safely.

What information must be reported on 51 0(k) Summary?

The 510(k) Summary must report information such as device name, intended use, description, substantial equivalence claims, labeling, and summary of safety and effectiveness data.