Get the free 510(K) SUMMARY - accessdata fda

This document serves as a summary of the 510(k) submission for the CARTO® 3 EP Navigation System, outlining its general information, description, indications for use, and related regulatory details.

How to fill out 510k summary - accessdata

How to fill out 510(K) SUMMARY

1. Begin by gathering all relevant information about the device.
2. Identify the predicate device that your device is based upon.
3. Prepare a description of the device, including its intended use and technological characteristics.
4. Collect data on performance testing, including any clinical or laboratory studies.
5. Include a comparison of your device to the predicate device in terms of indications for use, technological characteristics, and performance.
6. Organize the summary according to the FDA's requirements, ensuring all necessary sections are included.
7. Review the summary for accuracy and completeness.
8. Submit the 510(k) summary as part of the premarket notification to the FDA.

Who needs 510(K) SUMMARY?

1. Manufacturers of medical devices that are not exempt and wish to market their products in the U.S.
2. Companies looking to establish equivalence to an existing device (predicate) in order to gain FDA approval.
3. Professionals involved in the design and development of medical devices.

People Also Ask about

What is the 510k decision making 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 510k pathway?

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) 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 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 purpose of a 510 K to determine?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

What is the 501k process?

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 it take to get a 510 K approval?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 days.

For pdfFiller’s FAQs

What is 510(K) SUMMARY?

The 510(K) Summary is a document submitted to the FDA that provides information about a medical device to demonstrate that it is safe and effective by showing it is substantially equivalent to a device already approved.

Who is required to file 510(K) SUMMARY?

Manufacturers of medical devices that are not exempt from premarket notification and who want to market their products in the United States are required to file a 510(K) Summary.

How to fill out 510(K) SUMMARY?

To fill out the 510(K) Summary, manufacturers must provide details about the device, including its intended use, technological characteristics, safety and effectiveness data, and how it compares to predicate devices.

What is the purpose of 510(K) SUMMARY?

The purpose of the 510(K) Summary is to facilitate the FDA's review of a device to ensure that it is substantially equivalent to one that is already legally marketed, ensuring safety and efficacy before it reaches consumers.

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

The 510(K) Summary must include the submitter's name and address, device name, 21 CFR section, intended use, descriptions of the device, comparisons to predicate devices, and any clinical or non-clinical data supporting the claims.