Get the free 510(k) Summary - accessdata fda

This document provides a summary of the 510(k) traditional premarket notification submission for a new OTC dental device, Super Seal® Tooth Desensitizer, including device description, intended use,

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device type and its intended use.
2. Gather information on similar devices already on the market.
3. Prepare a detailed description of the device, including its design, materials, and mechanisms.
4. Conduct performance testing to demonstrate safety and effectiveness.
5. Compile information on manufacturing processes and quality control measures.
6. Draft the 510(k) summary including all relevant data and comparisons.
7. Submit the 510(k) summary to the FDA through their eSubmission system.
8. Respond to any FDA queries or requests for additional information.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are similar to existing marketed devices.
2. Developers of new medical devices seeking to demonstrate equivalence to a predicate.
3. Companies introducing modifications to existing devices that could affect safety or effectiveness.
4. Importers of medical devices needing to ensure compliance with FDA 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?

A 510(k) Summary is a document submitted to the FDA that provides a summary of the safety and effectiveness of a medical device intended for commercial distribution in the U.S. It is required to demonstrate that the device is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are intended to be marketed in the U.S. are required to file a 510(k) Summary if they are seeking to demonstrate that their device is substantially equivalent to an existing device.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must collect and compile required information including device description, intended use, regulatory history, comparison to predicate devices, and safety and effectiveness data. They must then complete the appropriate forms and format the Summary as per FDA guidelines.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA and the public with information about the device's intended use, technology, and the basis for determining substantial equivalence to a predicate device, ensuring regulatory compliance and safety.

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

The 510(k) Summary must report information including device identification, intended use, technological characteristics, comparison to predicate devices, performance testing results, labeling, and any risk management practices implemented.