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This document provides a summary of safety and effectiveness information for the feel-DRCS software, a digital X-ray image processing system, submitted in compliance with FDA regulations for medical

How to fill out 510k summary - accessdata

How to fill out 510(k) SUMMARY

1. Identify the device for which you are submitting the 510(k) SUMMARY.
2. Determine the predicate device that your device is similar to.
3. Gather applicable data to demonstrate substantial equivalence to the predicate device.
4. Complete the 510(k) application form, including a description of the device.
5. Provide information on the intended use and indications for use of the device.
6. Include labeling and promotional materials relevant to the device.
7. Compile performance testing data, if applicable, including safety and effectiveness.
8. Review the summary for completeness and compliance with FDA guidelines.
9. Submit the 510(k) SUMMARY electronically through the FDA's submission portal.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices intended for commercial distribution in the U.S.
2. Companies seeking to market a new device that is substantially equivalent to an existing device.
3. Organizations aiming to modify an existing device that requires FDA clearance.

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 that provides a summary of the safety and effectiveness of a medical device submitted for FDA clearance. It is part of the premarket notification process which allows manufacturers to demonstrate that their device is substantially equivalent to a legally marketed device.

Who is required to file 510(k) SUMMARY?

Manufacturers of medical devices that are intended for commercial distribution in the United States must file a 510(k) SUMMARY if their device is not exempt from this submission and it is intended for humans.

How to fill out 510(k) SUMMARY?

To fill out a 510(k) SUMMARY, manufacturers must gather necessary information about the device, including its intended use, specifications, and comparisons to predicate devices, and then complete the forms as outlined by the FDA guidance documents.

What is the purpose of 510(k) SUMMARY?

The purpose of the 510(k) SUMMARY is to allow the FDA to assess whether a medical device is safe and effective based on information provided by the manufacturer about its design, intended use, performance, and any similarities to existing devices.

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

The 510(k) SUMMARY must include information such as the device's name, description, intended use, technological characteristics, comparison with predicate devices, and performance testing results, including any clinical data if applicable.