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This document summarizes the 510(k) submission for the Care back pain relief stimulator, identifying its intended use for temporary relief of pain in the lower back. It details the device's technological

How to fill out 510k summary - accessdata

How to fill out 510(k) SUMMARY

1. Identify the device: Determine the specific medical device you are submitting a 510(k) for.
2. Gather necessary information: Collect all relevant data and documentation about the device, including device description, intended use, and technological characteristics.
3. Determine predicates: Identify at least one legally marketed device (predicate) that is similar to your device.
4. Prepare the summary: Write a summary that includes device information, comparisons with predicate devices, and safety and effectiveness data.
5. Include any additional information: Attach any relevant studies, testing results, and labeling information that support your submission.
6. Review the summary: Ensure that your information is clear, concise, and adheres to FDA guidelines before submitting.
7. Submit the 510(k): File the completed 510(k) summary electronically through the FDA’s submission system.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices that are not exempt from premarket notification requirements and seek to market a new device in the U.S.
2. Companies introducing modifications or significant changes to an existing medical device that could affect its safety or effectiveness.
3. Entities seeking to demonstrate that their device is substantially equivalent to a previously cleared device.

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 by manufacturers to demonstrate that their medical device is substantially equivalent to a legally marketed device, ensuring safety and effectiveness.

Who is required to file 510(k) SUMMARY?

Manufacturers of medical devices that fall into certain categories or are not exempt from premarket notification are required to file a 510(k) SUMMARY with the FDA before marketing their devices.

How to fill out 510(k) SUMMARY?

To fill out a 510(k) SUMMARY, manufacturers must provide information about the device, including its intended use, technological characteristics, and comparisons to predicate devices, supported by clinical data when necessary.

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, demonstrating that it is equivalent to an already legally marketed device.

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

The information that must be reported on a 510(k) SUMMARY includes the device details, manufacturer information, intended use, comparison to predicate devices, and results from any required testing or clinical studies.