Get the free 510(k) Summary - accessdata fda

This document provides a summary of the safety and effectiveness information for the Slim Onebody System dental implant, submitted according to FDA requirements.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device: Clearly define the medical device you are submitting.
2. Determine the predicate device: Find a legally marketed device that is similar to yours.
3. Prepare the summary: Include device description, intended use, technological characteristics, and comparison to the predicate.
4. Include performance data: Summarize the non-clinical and clinical testing that supports your device's safety and effectiveness.
5. Draft the labeling information: Provide labels, instructions for use, and promotional materials.
6. Submit to the FDA: Complete the required forms and submit your 510(k) Summary electronically.

Who needs 510(k) Summary?

1. Manufacturers of medical devices who are seeking FDA clearance to market their products in the U.S.
2. Companies that are introducing new devices that are substantially equivalent to an already FDA-approved product.
3. Entities looking to ensure compliance with regulatory requirements for device safety and effectiveness.

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 outlines the safety and effectiveness of a medical device, often used to demonstrate substantial equivalence to a device already on the market.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not exempt from regulation and wish to market devices that are substantially equivalent to an already legally marketed device are required to file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, applicants must complete the required sections of the FDA's 510(k) submission form, provide descriptions of the device, its intended use, and any relevant data demonstrating its safety and effectiveness.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with a review of the device's safety and effectiveness and to establish substantial equivalence to a pre-existing device.

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

The 510(k) Summary must include the device name, intended use, description, comparison to predicate devices, performance data, labeling, and any relevant testing results.