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This document provides a summary of the 510(k) premarket notification for the Paltop Advanced Dental Solutions Implant System, detailing its intended use, device description, and compliance with regulatory

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 if your device is substantially equivalent to an existing device.
3. Gather all necessary documentation, including device description, intended use, and labeling.
4. Conduct performance tests and gather results that support the claims made in the summary.
5. Complete the FDA 510(k) form with your company information and details about the device.
6. Prepare a summary of safety and effectiveness based on your test results and comparisons with predicate devices.
7. Include any additional information required by the FDA, such as biocompatibility data or sterility information.
8. Review the entire summary to ensure completeness and accuracy before submission.
9. Submit the 510(k) SUMMARY electronically through the FDA's submission portal.

Who needs 510(k) SUMMARY?

1. Manufacturers of medical devices who wish to market their products in the United States.
2. Companies introducing a new device that is similar to an already marketed device.
3. Developers seeking to demonstrate that their device is as safe and effective as a predicate 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?

A 510(k) SUMMARY is a document submitted to the FDA that provides information about a medical device and demonstrates that it is safe and effective for its intended use, often by showing substantial equivalence to a previously cleared device.

Who is required to file 510(k) SUMMARY?

Manufacturers of medical devices that are considered Class II or some Class I devices that are not exempt from the premarket notification process are required to file a 510(k) SUMMARY before marketing their devices.

How to fill out 510(k) SUMMARY?

To fill out a 510(k) SUMMARY, manufacturers should provide detailed information about the device, including its description, intended use, technological characteristics, identification of predicate devices, performance data, labeling, and any other information required by the FDA.

What is the purpose of 510(k) SUMMARY?

The purpose of a 510(k) SUMMARY is to demonstrate to the FDA that a new medical device is substantially equivalent to an existing, legally marketed device, thereby providing assurance of its safety and effectiveness.

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

The 510(k) SUMMARY must include information such as the device name, intended use, description, predicate device comparison, manufacturing information, and any relevant safety and effectiveness data.