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This document provides a safety and effectiveness summary for the Mission Saliva Alcohol Test Strip submitted to the FDA, detailing its intended use, technological characteristics, and comparison

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device type and classification.
2. Gather necessary information about the device, including its design, materials, and intended use.
3. Prepare a detailed description of the device, including specifications and performance characteristics.
4. Identify the predicate device(s) that your device is compared to.
5. Provide information about the safety and effectiveness of your device.
6. Compile the necessary clinical data, if applicable.
7. Complete the 510(k) form with all relevant information and submit it to the FDA.
8. Include a summary of any risks associated with the device and how they will be mitigated.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are not exempt from 510(k) requirements.
2. Companies seeking to market a new device that is substantially equivalent to an existing device.
3. Developers of modifications to existing devices that may affect safety or 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?

A 510(k) Summary is a document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about a medical device that is being submitted for premarket review. It outlines the device's intended use, technological characteristics, and any safety and efficacy data used to establish substantial equivalence to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are classified as Class II or some Class I devices that are not exempt must file a 510(k) Summary when they wish to market a new device that is substantially equivalent to an existing device. This applies to both domestic and foreign manufacturers.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers should follow the FDA's guidelines, which include providing information such as the device's name, description, intended use, technological characteristics, performance standards, and comparison with predicate devices. Tools and templates are often provided by the FDA to assist in the completion of the document.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to demonstrate to the FDA that the new medical device is safe and effective by proving substantial equivalence to a predicate device that is already publicly marketed. It ensures that devices meet regulatory requirements before they can be sold.

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

The 510(k) Summary must include the device's name, identification information, detailed description of the device, intended use, technological characteristics, performance data, labeling, and the name of the predicate device used for comparison. Any safety and effectiveness data relevant to the device must also be presented.