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This document summarizes the 510(k) premarket notification for the INFU Box Type 0412A, a device intended for the regulation of temperature of intravenous fluids prior to administration.

How to fill out 510k summary- traditional submission

How to fill out 510(k) Summary- Traditional Submission

1. Determine if your device is eligible for a 510(k) submission.
2. Gather necessary information about your device, including its purpose, indications for use, and performance specifications.
3. Identify the predicate device(s) to which your device is comparable.
4. Prepare a summary of the device’s technological characteristics and any differences from the predicate.
5. Conduct necessary testing and gather data to support the safety and effectiveness of your device.
6. Draft the 510(k) summary, including a table comparing your device with the predicate device.
7. Include any labeling information relevant to your device.
8. Review the summary to ensure all required elements are included and accurate.
9. Submit the 510(k) summary to the FDA through their electronic submission process.

Who needs 510(k) Summary- Traditional Submission?

1. Manufacturers of medical devices that intend to market a device in the U.S. and need to establish that their device is safe and effective by demonstrating substantial equivalence to a predicate device.

People Also Ask about

What is 510k submission summary?

The basis for the 510(k) submission is to show that your new device is safe and effective, because it's a lot like another device that's already been reviewed and cleared by the FDA. Go step by step through the devices and show how the indications for use, technology, and performance are the same or equivalent.

How to prepare a 510 K submission?

Your 510(k) submission should: Demonstrate your medical device is 'substantially equivalent' to a predicate already on the market. House detailed technical, safety and performance device/test information to show your device is safe and effective. Prove you have a robust medical device quality and risk management system.

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 is 510k summary report?

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) that is not subject to premarket approval.

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.

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.

For pdfFiller’s FAQs

What is 510(k) Summary- Traditional Submission?

The 510(k) Summary - Traditional Submission is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective and substantially equivalent to a legally marketed device. This pathway is commonly used for devices that are not subject to Premarket Approval (PMA).

Who is required to file 510(k) Summary- Traditional Submission?

Manufacturers of medical devices that intend to market a device in the United States and believe their device is substantially equivalent to an existing, legally marketed device are required to file a 510(k) Summary - Traditional Submission.

How to fill out 510(k) Summary- Traditional Submission?

To fill out a 510(k) Summary - Traditional Submission, manufacturers must complete specific forms provided by the FDA, incorporate necessary technical information, detail the device's intended use, and provide comparisons to the predicate device. It's important to follow the latest guidance documents provided by the FDA.

What is the purpose of 510(k) Summary- Traditional Submission?

The purpose of the 510(k) Summary - Traditional Submission is to provide the FDA with sufficient information to determine whether the device is safe and effective, ensuring that it meets regulatory standards before it can be marketed.

What information must be reported on 510(k) Summary- Traditional Submission?

The 510(k) Summary - Traditional Submission must include device identification, description, intended use, manufacturing information, labeling, performance data, and a comparison to a predicate device. Additionally, any safety and effectiveness data must also be provided.