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This document provides a summary of a medical device, specifically a hydrogel wound dressing, including its intended use, technological characteristics, and details regarding the predicate devices.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device for which you are seeking clearance.
2. Determine the appropriate predicate device that is already on the market.
3. Gather the necessary device descriptions, including intended use and indications for use.
4. Conduct a thorough comparison with the predicate device, including similarities and differences.
5. Compile information on device performance, including any testing results.
6. Include labeling information, such as instructions for use and any promotional materials.
7. Prepare a summary of safety and effectiveness information.
8. Organize all your documentation clearly and concisely according to FDA guidelines.
9. Submit the finalized 510(k) summary to the FDA through the appropriate electronic submission system.

Who needs 510(k) Summary?

1. Manufacturers seeking to market medical devices that are substantially equivalent to a legally marketed device.
2. Companies looking to obtain FDA clearance for new medical devices or modifications to existing devices.
3. Organizations that need to provide proof of safety and effectiveness of their medical devices to regulatory authorities.

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 information about a medical device's safety and effectiveness in order to demonstrate that it is substantially equivalent to a device already on the market.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that intend to market their products in the United States and believe their device is substantially equivalent to a legally marketed predicate device are required to file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, the applicant must provide detailed information about the device, including its intended use, technological characteristics, comparison to predicate devices, and any supporting data related to safety and effectiveness.

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 proposed device, ensuring that it meets regulatory standards for safety and effectiveness and is comparable to existing devices.

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

The 510(k) Summary must report information such as device name, intended use, description, classification, predicate device details, technological characteristics, and any performance or safety testing data.