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This document details the 510(k) premarket notification for the Lifelines Photic Stimulator, including device description, indications for use, and a comparison with a predicate device, ensuring compliance

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device that requires the 510(k) submission.
2. Determine the appropriate predicate device that demonstrates safety and effectiveness.
3. Gather data, including performance testing, materials used, and labeling information.
4. Create a summary of the device's intended use, technological characteristics, and any differences from the predicate device.
5. Organize the information into the required format as specified by the FDA.
6. Review and ensure all information is accurate and complete.
7. Submit the 510(k) Summary to the FDA through the Electronic Submissions Gateway.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are not exempt from premarket notification, including those introducing a new device that is substantially equivalent to a legally marketed one.

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 the device is safe and effective for its intended use, and is substantially equivalent to a device already on the market.

Who is required to file 510(k) Summary?

Manufacturers of medical devices who wish to market a device that is not exempt from premarket notification must file a 510(k) Summary with the FDA.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers should follow the FDA's guidelines, providing detailed information about the device's identity, intended use, technological characteristics, and any clinical or nonclinical data supporting its safety and effectiveness.

What is the purpose of 510(k) Summary?

The purpose of a 510(k) Summary is to inform the FDA and the public about the characteristics and performance of a medical device, affirming its equivalence to a legally marketed device and ensuring safety and effectiveness.

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

The information that must be reported includes device name, intended use, manufacturing information, labeling, safety and effectiveness data, and a comparison to a predicate device.