Get the free 510(k) Summary - accessdata fda

This document is a 510(k) summary required by the FDA, detailing the submission of a dental imaging software and sensor system, CLIO/CLIOSOFT, for regulatory approval.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and its intended use.
2. Determine the classification of your device.
3. Gather data on similar legally marketed devices (predicate devices).
4. Compile necessary safety and effectiveness information.
5. Prepare and organize the 510(k) submission documents.
6. Complete the required 510(k) Summary template.
7. Submit the completed 510(k) Summary to the FDA.

Who needs 510(k) Summary?

1. Manufacturers of medical devices seeking market approval in the United States.
2. Companies introducing a new device that is substantially equivalent to an existing device.
3. Any organization intending to market devices for human use in the U.S. that require premarket notification.

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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 that provides information about a medical device that is submitted to the FDA to demonstrate that the device is safe and effective by showing that it is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are intended for commercial distribution and are classified as Class II devices, as well as some Class I devices, are required to file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary?

To fill out the 510(k) Summary, manufacturers must complete the FDA's 510(k) application form, provide detailed device descriptions, demonstrate substantial equivalence to a predicate device, include intended use and technological characteristics, and submit supporting data including safety and effectiveness information.

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 device, its intended use, any adverse effects, and how it compares to existing devices to ensure safety and effectiveness.

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

The 510(k) Summary must include information such as the device name and classification, the manufacturer’s contact information, description of the device, intended use, predicate devices, performance testing results, and any labeling information.