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This document summarizes the safety and effectiveness information for the Thermo Scientific MAS® Omni-IMMUNE and Omni-IMMUNE PRO medical devices, submitted in accordance with FDA requirements for

How to fill out 510k summary - accessdata

How to fill out 510K SUMMARY

1. Begin with the basic information, including the name, address, and contact information for the applicant.
2. Provide the proposed device name and its intended use.
3. Describe the device's classification and any applicable regulations.
4. Summarize the predicate device(s) to which the new device is compared.
5. Outline the device specifications, design, and materials used.
6. List the indications for use and summarize the intended patient population.
7. Provide safety and effectiveness data, including any clinical data if required.
8. Discuss any potential risks associated with the device and how they will be mitigated.
9. Conclude with a summary statement of how the device is safe and effective for its intended use.

Who needs 510K SUMMARY?

1. Manufacturers who are intending to market a medical device that is substantially equivalent to a predicate device.
2. Companies seeking to modify an existing medical device.
3. Start-ups and organizations developing new medical devices that fall under FDA regulation.

People Also Ask about

What is the difference between FDA 510k and CE?

Time Duration for Approval CE Mark: On average, the process takes about four to six weeks. However, it can take longer if the product still needs to be modified or if the technical documentation is not yet complete. US FDA 510(k) Clearance: On average, the process takes about 177 days (about 6 months).

How to view 510 k submissions?

Users can search the FDA 510(k) database by entering the name of a specific medical device, the name of the applicant who filed the 510(k) premarket notification paperwork for the device, or by entering the specific 510(k) number or product code associated with a given device.

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.

What is the 510k clearance process?

The FDA 510k submission requirements include extensive technical documentation such as proposed labeling, sterilization and shelf life data, biocompatibility research, animal, clinical and bench performance testing and other technical evidence needed to establish substantial equivalence and receive FDA 510k clearance.

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 difference between abbreviated 510k and traditional 510k?

While the traditional program requires detailed documentation, abbreviated 510k requires summarized reports on standard compliance with DOC. Therefore, an FDA reviewer may take less time to review abbreviated 510k documents and make faster decisions.

What are the three types of 510k?

Overview. A submitter may choose from three types of Premarket Notification 510(k) submissions to seek marketing clearance for their device when appropriate for review under the 510(k) Program: Traditional, Special, and Abbreviated.

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 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 510k approval requirements?

A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. the information submitted to FDA demonstrates that the device is as safe and effective as the legally marketed device.

For pdfFiller’s FAQs

What is 510K SUMMARY?

The 510(k) summary is a document submitted to the FDA that provides information about a medical device, including its intended use and how it is substantially equivalent to a legally marketed device.

Who is required to file 510K SUMMARY?

Manufacturers of medical devices intending to market their products in the U.S. must file a 510(k) summary if their device is not exempt from premarket notification requirements.

How to fill out 510K SUMMARY?

To fill out the 510(k) summary, manufacturers must provide detailed information about the device, including descriptions, intended use, device comparisons, and data supporting safety and effectiveness.

What is the purpose of 510K SUMMARY?

The purpose of the 510(k) summary is to demonstrate to the FDA that the new medical device is safe and effective, and substantially equivalent to a device already on the market.

What information must be reported on 510K SUMMARY?

The 510(k) summary must include information such as device identification, description, intended use, technological characteristics, performance data, and comparisons to predicate devices.