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This document provides a summary of the safety and effectiveness of the SonoScape SSI-8000 Mobile Digital Color Doppler Ultrasound System, submitted in accordance with the SMDA 1990 and related FDA

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device class and appropriate regulations for your device.
2. Gather information about the device design, intended use, and performance characteristics.
3. Prepare a comprehensive comparison of your device to a legally marketed predicate device.
4. Organize the required documentation, including labeling, testing data, and any clinical studies if applicable.
5. Complete the 510(k) form accurately, including all necessary details and supporting documentation.
6. Submit the 510(k) report through the FDA's electronic submission system.
7. Respond to any questions or requests for additional information from the FDA during the review process.

Who needs 510(k) Summary?

1. Manufacturers or importers of medical devices that are not exempt and intend to market a device in the U.S.
2. Companies that are introducing a modified version of an already marketed device.
3. Any entity that wants to ensure their device is compliant with FDA regulations before market release.

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 submitted to the FDA that provides information about a medical device, demonstrating that it is substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not exempt from premarket notification requirements are required to file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers should gather information about the device, including its intended use, technological characteristics, and substantial equivalence to a predicate device, and then complete the FDA's 510(k) template.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with information necessary to determine whether the medical device is safe and effective for its intended use and to ensure regulatory compliance.

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

The 510(k) Summary must include device name, manufacturer details, intended use, description of the device, comparisons to predicate devices, labeling information, and performance data.