Get the free 510(k) Summary - accessdata fda

This document provides a summary of the 510(k) premarket notification for the LEW Mini 0-Ball Implant submitted by Park Dental Research Corporation. It outlines the device's descriptions, indications

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Gather necessary information about the device, including its intended use and technological characteristics.
2. Identify the appropriate predicate device that has already received 510(k) clearance.
3. Prepare a description of the device, including its design, materials, and components.
4. Conduct performance testing to demonstrate that the new device is as safe and effective as the predicate device.
5. Compile labeling information, including instructions for use and marketing claims.
6. Fill out the 510(k) application form with the gathered information and any supporting data.
7. Submit the 510(k) application to the FDA and pay any required fees.
8. Address any questions or requests for additional information from the FDA during their review.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are significantly different from previously marketed devices need to submit a 510(k) Summary.
2. Companies seeking to market new devices that may be substantially equivalent to existing devices need a 510(k) Summary.
3. Importers intending to bring medical devices into the U.S. must also comply with 510(k) regulations.

People Also Ask about

What are the three types of 510k?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the 510k pathway?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

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.

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 difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

The 510(k) Summary is a document submitted to the FDA that demonstrates that a medical device is safe and effective by showing that it is substantially equivalent to another legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are classified as Class II or certain Class I devices are required to file a 510(k) Summary before marketing their products.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must include sections detailing the device description, intended use, indications for use, comparison to predicate devices, and supporting data, among other required elements.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA and the public with a concise overview of the device's intended use, technological characteristics, and the rationale for determining substantial equivalence to a predicate device.

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

The 510(k) Summary must report device identification, manufacturer information, intended use, technological characteristics, performance testing data, and any relevant safety and effectiveness information.