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This document outlines the premarket submission for the gi4000 Electrosurgical Generator, including device description, indications for use, regulatory classification, and compliance with FDA requirements.

How to fill out traditional 510k premarket submission

How to fill out Traditional 510(k) Premarket Submission

1. Identify the device you want to submit for clearance.
2. Determine if your device is substantially equivalent to a predicate device.
3. Compile the necessary information, including device description, intended use, and any applicable performance data.
4. Prepare labeling information, including instructions for use and marketing materials.
5. Complete the 510(k) form, providing all required information in a clear and organized manner.
6. Include any relevant clinical data, testing results, or risk assessments if applicable.
7. Review the submission for compliance with FDA requirements.
8. Submit the 510(k) electronically or via mail to the appropriate FDA division.
9. Monitor the submission status and respond to any additional requests from the FDA during the review process.

Who needs Traditional 510(k) Premarket Submission?

1. Manufacturers of medical devices that wish to market their products in the U.S. that are similar to existing, legally marketed devices.
2. Companies looking to demonstrate substantial equivalence to a predicate device before they can introduce their devices into the market.
3. Developers of new medical technologies that do not meet the criteria for a PMA (Premarket Approval) but require FDA clearance to ensure safety and efficacy.

People Also Ask about

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 difference between 510K and premarket approval?

What's the difference between a 510K vs PMA? 510(k) clearance is authorisation from the FDA to market a medium-risk medical device, while PMA (premarket approval) is required for more high-risk and novel products.

How long will it take my 510 K to be cleared by the US FDA?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

What are the elements of a 510 K premarket notification submission?

The first two sections of your 510(k) submission consist entirely of FDA forms for you to complete. Section 1.0 is the Medical Device User Fee Cover Sheet (FDA Form 3601) and Section 2.0 is the CDRH Premarket Review Submission Cover Sheet (FDA Form 3514). Seems pretty straightforward right?

What is the difference between premarket notification and 510k?

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.

How long does it take for the 510 K determination in the case of traditional premarket notification?

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 rejection rate for 510K?

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.

For pdfFiller’s FAQs

What is Traditional 510(k) Premarket Submission?

A Traditional 510(k) Premarket Submission is a regulatory pathway for medical devices to demonstrate that they are substantially equivalent to a legally marketed device. It is submitted to the FDA for review and clearance before marketing.

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

Manufacturers of medical devices that are seeking to market a device that is not exempt from premarket notification, and which is substantially equivalent to another legally marketed device (predicate device) are required to file a Traditional 510(k) Premarket Submission.

How to fill out Traditional 510(k) Premarket Submission?

Filling out a Traditional 510(k) involves compiling necessary documentation that includes device description, intended use, labeling, performance testing, and comparative analysis with the predicate device. The form must be completed following FDA guidelines, and all required information must be included.

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

The purpose of a Traditional 510(k) Premarket Submission is to obtain FDA clearance to market a medical device by demonstrating that it is as safe and effective as a previously approved (predicate) device.

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

The information required includes the device name, device classification, intended use, performance data, labeling, summary of technological characteristics, and evidence of substantial equivalence to predicate devices.