Get the free 510(k) Summary - accessdata fda

This document provides a summary of the 510(k) safety and effectiveness information for the HL568 Self-Monitoring Blood Glucose System, including its intended use, device description, and comparison

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and its intended use.
2. Choose the appropriate pathway under the 510(k) process.
3. Gather the necessary documentation, including device description and materials.
4. Conduct a risk assessment to establish safety and effectiveness.
5. Compile any performance data required, such as bench, animal, or clinical testing.
6. Draft the 510(k) summary, including all relevant details about the device.
7. Submit the 510(k) application to the FDA along with the summary and any supporting documents.
8. Respond to any FDA requests for additional information or clarification.

Who needs 510(k) Summary?

1. Manufacturers of medical devices looking to market a new product that is substantially equivalent to an existing device.
2. Companies that have made modifications to existing devices and need to demonstrate that they are still safe and effective.
3. Importers of medical devices who are bringing products into the U.S. market.

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, demonstrating that it is safe and effective for its intended use, and substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not classified as Class I or II (that do not qualify for exemption) and who intend to market a device that is substantially equivalent to a device already on the market are required to file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must gather data about their device, including its description, intended use, technology, labeling, comparison to predicate devices, and performance testing results, and submit this information according to FDA guidelines.

What is the purpose of 510(k) Summary?

The purpose of a 510(k) Summary is to demonstrate to the FDA that a new medical device is safe and effective by showing it is substantially equivalent to a device already cleared for marketing.

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

The 510(k) Summary must include information such as device name, intended use, technology type, comparison to predicate device, description of the device, and a summary of safety and effectiveness data.