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This document provides a summary of the safety and effectiveness of the DC-3/DC-3T Diagnostic Ultrasound System, submitted to the FDA in accordance with regulatory requirements. The device is a mobile,

How to fill out 510k summary - accessdata

How to fill out 510(k) SUMMARY

1. Identify the device: Clearly define the medical device that you are submitting for 510(k) clearance.
2. Determine predicate devices: Research and identify the predicate devices that are already legally marketed and most similar to your device.
3. Prepare the summary: Create a comprehensive summary that includes the device description, intended use, and technological characteristics.
4. Include performance data: Provide any relevant performance data that supports the safety and effectiveness of your device.
5. Document safety and effectiveness: Summarize the safety and effectiveness of your device using the information from the predicate and performance data.
6. Compile references: Include references to any relevant standards or guidelines that were followed during development.
7. Review and format: Ensure that the summary is well-organized, clearly written, and formatted according to FDA guidelines.
8. Submit the summary: Attach the completed 510(k) summary to your 510(k) application for FDA review.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices that are substantially equivalent to a legally marketed device.
2. Companies seeking clearance to market a new device that may pose a risk to health and safety.
3. Startups developing innovative medical technologies that require FDA approval before distribution.
4. Existing companies looking to expand their product line with additional devices.

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 about a medical device, demonstrating that it is safe and effective for its intended use, and is substantially equivalent to an already legally marketed device.

Who is required to file 510(k) SUMMARY?

Manufacturers of medical devices that are not exempt from premarket notification and are seeking marketing clearance to introduce a new device or to make modifications to an existing device are required to file a 510(k) SUMMARY.

How to fill out 510(k) SUMMARY?

To fill out a 510(k) SUMMARY, manufacturers must provide detailed information including device descriptions, intended use, technological characteristics, labeling, and a summary of the comparison with predicate devices, as well as relevant safety and effectiveness data.

What is the purpose of 510(k) SUMMARY?

The purpose of the 510(k) SUMMARY is to ensure that new or modified medical devices meet safety and effectiveness standards before they can be marketed, facilitating the FDA's review process.

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

The information reported on a 510(k) SUMMARY includes device identification, intended use, description of the device, comparison to predicate devices, summaries of non-clinical and clinical data, labeling and proposed labeling, and a statement regarding the conclusions drawn from the safety and effectiveness data.