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This document provides a summary of the 510(k) premarket notification for the Symbiq Infusion System, detailing its safety and effectiveness, intended use, technological characteristics, and substantial

How to fill out 510k summary - accessdata

How to fill out 510(k) SUMMARY

1. Determine if your device is subject to 510(k) requirements.
2. Identify the appropriate regulatory pathway for your device.
3. Conduct a thorough literature review and gather necessary data.
4. Prepare the 510(k) submission including device description, intended use, and comparisons to predicate devices.
5. Compile all supporting documents such as test results, labeling, and manufacturing information.
6. Complete the 510(k) Summary or 510(k) Statement as per FDA guidance.
7. Submit the completed 510(k) to the FDA for review.
8. Respond to any additional information requests from the FDA as necessary.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices planning to market a device in the U.S. that is not exempt from premarket notification.
2. Companies introducing a new device or making significant changes to an existing device that may affect safety or effectiveness.
3. Importers wishing to market foreign-manufactured medical devices in the United States.

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 document submitted to the FDA that provides information on a medical device's safety and effectiveness, demonstrating that it is substantially equivalent to a legally marketed device.

Who is required to file 510(k) SUMMARY?

Manufacturers of certain medical devices that are not exempt from premarket notification requirements and are seeking to market their devices in the U.S. must file a 510(k) SUMMARY.

How to fill out 510(k) SUMMARY?

To fill out a 510(k) SUMMARY, you need to gather required information about the device, including its intended use, design, materials, and performance data. You can then follow the FDA's guidelines to accurately complete the form and include all relevant documentation.

What is the purpose of 510(k) SUMMARY?

The purpose of the 510(k) SUMMARY is to inform the FDA and the public about the device's safety and effectiveness based on its comparison to similar existing devices, ensuring that it meets regulatory standards.

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

The 510(k) SUMMARY must report information including the device name, description, intended use, technological characteristics, performance data, labeling, and a summary of safety and effectiveness data.