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This document presents the 510(k) premarket notification for the Prevena TM Incision Management System, outlining its equivalence to predicate devices and details on its intended use, device description,

How to fill out 510k summary - accessdata

How to fill out 510(k) SUMMARY

1. Gather necessary information about the device, including its intended use and technological characteristics.
2. Determine if your device qualifies for 510(k) submission by comparing it to a legally marketed device.
3. Prepare the 510(k) Summary document by clearly stating the device's name, classification, and common name.
4. Provide a description of the device, including specifications and any applicable standards.
5. Detail the intended use and indications for use of the device.
6. Include data supporting substantial equivalence, such as performance testing and clinical data if necessary.
7. Review and include any labeling information and user instructions.
8. Submit the prepared 510(k) Summary along with the necessary application fee to the FDA.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices who wish to market a device in the U.S. that is substantially equivalent to an existing device.
2. Companies looking to gain FDA clearance for new or modified devices before they can be sold.

People Also Ask about

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.

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 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 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.

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.

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.

For pdfFiller’s FAQs

What is 510(k) SUMMARY?

The 510(k) SUMMARY is a submission made to the FDA that demonstrates that a medical device is substantially equivalent to a device already legally marketed in the U.S. and therefore safe and effective for its intended use.

Who is required to file 510(k) SUMMARY?

Manufacturers of medical devices that are classified in class II or devices that need to demonstrate substantial equivalence to an existing device are required to file a 510(k) SUMMARY with the FDA.

How to fill out 510(k) SUMMARY?

To fill out a 510(k) SUMMARY, manufacturers must provide information such as device description, intended use, technology comparison with predicate devices, performance testing data, and labeling information in accordance with FDA guidelines.

What is the purpose of 510(k) SUMMARY?

The purpose of the 510(k) SUMMARY is to provide a comprehensive overview of the medical device's safety and effectiveness, ensuring that it meets FDA requirements and is safe for public use before it is marketed.

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

Information reported on the 510(k) SUMMARY must include device identification, intended use, technological characteristics, indications for use, performance data, and a comparison to predicate devices.