Get the free 510(K) SUMMARY - accessdata fda

A summary document for the 510(k) premarket notification of the SONOLITH® i-move module and tables, outlining the device's sponsor information, device description, regulatory classification, intended

How to fill out 510k summary - accessdata

How to fill out 510(K) SUMMARY

1. Identify the device: Start by determining the device's classification and if it requires a 510(k) submission.
2. Gather device information: Collect data on the device's design, materials, components, and intended use.
3. Conduct performance testing: Perform necessary tests to demonstrate the device's safety and effectiveness.
4. Prepare a comparison: Identify a legally marketed device (predicate device) and provide a comparison in terms of safety and efficacy.
5. Compile supporting documents: Include the necessary documentation such as labeling, instructions for use, and manufacturing details.
6. Write the summary: Create a 510(k) summary that presents all the collected information in a clear and concise manner.
7. Submit the 510(k): Complete the required forms and submit the summary along with the supporting documents to the FDA.

Who needs 510(K) SUMMARY?

1. Manufacturers of medical devices that are intended for commercial distribution in the United States.
2. Companies introducing new devices that are similar to existing ones already approved by the FDA.
3. Any entity that seeks to demonstrate that their device is safe and effective through substantial equivalence to a predicate device.

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?

A 510(k) summary is a document submitted to the U.S. Food and Drug Administration (FDA) that provides a summary of the safety and effectiveness of a medical device in order to demonstrate that it is substantially equivalent to a legally marketed device.

Who is required to file 510(K) SUMMARY?

Manufacturers of medical devices in the U.S. that are seeking to market a new device or a significantly modified version of an existing device are required to file a 510(k) summary if it is not exempt and if the device is classified as Class I or Class II.

How to fill out 510(K) SUMMARY?

To fill out a 510(k) summary, manufacturers must collect and compile relevant information about the device, including its intended use, technological characteristics, comparisons with predicate devices, and data supporting safety and effectiveness, then submit this information through the FDA's electronic submission system.

What is the purpose of 510(K) SUMMARY?

The purpose of the 510(k) summary is to provide the FDA with sufficient information to determine whether a device is safe and effective for its intended use and to ensure that it is substantially equivalent to an existing legally marketed device.

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

The 510(k) summary must include the device's name and description, intended use, a comparison to predicate devices, technological characteristics, performance testing results, labeling information, and any clinical data if applicable.