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This document provides a summary of the 510(k) premarket notification for the Ostial Pro Stent Positioning System, detailing its intended use, device description, technological characteristics, safety

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and its intended use.
2. Gather relevant data, including safety and effectiveness information.
3. Prepare a comprehensive summary that includes device description, technology comparison, and performance data.
4. Include any clinical data if required.
5. Review the summary for accuracy and completeness.
6. Submit the 510(k) summary along with the application to the FDA.

Who needs 510(k) Summary?

1. Manufacturers of medical devices seeking market clearance in the U.S.
2. Companies introducing modifications or new models of existing devices.
3. Importers and distributors of medical devices that require FDA clearance.

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) by medical device manufacturers to demonstrate that their device is safe and effective, 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 low risk and are seeking FDA clearance to market their devices must file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers should provide detailed information about their device, including its description, intended use, technological characteristics, and a comparison with a predicate device, along with testing results and labeling information.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to allow the FDA to evaluate the safety and effectiveness of a new medical device in relation to existing devices, ensuring that it can be safely used by the public.

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

The information that must be reported on a 510(k) Summary includes the device name, model, intended use, description, predicate device information, performance data, labeling, and any adverse effects.