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This document provides a 510(K) summary for the CSM Internal-R Implant System, detailing declarations of substantial equivalence with previously marketed dental implant devices, indications for use,

How to fill out 510k summary - accessdata

How to fill out 510(K) Summary

1. Identify the medical device you intend to submit for 510(k) review.
2. Gather all relevant documentation and data about the device, including design, materials, intended use, and operational principles.
3. Determine the predicate device that demonstrates substantial equivalence to your device.
4. Prepare a detailed description of your device and its intended use.
5. Include performance testing results and a summary of any clinical data, if applicable.
6. Ensure compliance with FDA guidance documents related to your device category.
7. Complete the 510(k) summary form and ensure all information is accurate and complete.
8. Submit the 510(k) summary along with the required fee through the FDA's electronic submission system.

Who needs 510(K) Summary?

1. Manufacturers of medical devices seeking to market their product in the USA.
2. Companies that are introducing a new device that is similar to an existing approved device.
3. Firms that need FDA clearance to demonstrate that their device is safe and effective.

People Also Ask about

What is the content of a special 510k?

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 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

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 the 510 K process?

Most 510(k)s will include some type of performance data. The extent of performance data will depend on the complexity of the device and its intended use and indications. Performance data should be provided to help demonstrate SE of your device to one or more legally marketed devices (predicate device).

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.

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.

For pdfFiller’s FAQs

What is 510(K) Summary?

The 510(K) Summary is a document submitted to the FDA by manufacturers seeking to market a medical device. It provides information about the device's safety and effectiveness in comparison to a legally marketed 'predicate' device.

Who is required to file 510(K) Summary?

Manufacturers of medical devices that are not exempt from premarket notification and are not classified as Class III devices typically must file a 510(K) Summary with the FDA before marketing their product.

How to fill out 510(K) Summary?

Filling out a 510(K) Summary involves providing detailed information about the device, including the intended use, technological characteristics, a comparison to the predicate device, and data that supports claims about safety and effectiveness.

What is the purpose of 510(K) Summary?

The purpose of the 510(K) Summary is to demonstrate to the FDA that the new device is safe and effective, and substantially equivalent to an existing legally marketed device, allowing it to be cleared for marketing.

What information must be reported on 510(K) Summary?

The information required includes the device name, intended use, description of the device, summary of technological characteristics, comparisons with predicate devices, and data supporting safety and effectiveness.