Get the free 510(k) Summary of Safety and Effectiveness Information - accessdata fda

A submission detailing the safety and effectiveness of the Bard® InlayOptima™ Ureteral Stent, providing device specifications, intended uses, and regulatory classifications as required by the FDA.

How to fill out 510k summary of safety

How to fill out 510(k) Summary of Safety and Effectiveness Information

1. Identify the device and its intended use.
2. Review previous 510(k) summaries and FDA guidance.
3. Gather clinical and non-clinical data demonstrating safety and effectiveness.
4. Summarize the data in clear, concise language.
5. Discuss any potential risks and how they are mitigated.
6. Include comparisons to predicate devices.
7. Ensure all required elements are included, such as indications for use, technological characteristics, and performance data.
8. Review and revise the summary for clarity and accuracy before submission.

Who needs 510(k) Summary of Safety and Effectiveness Information?

1. Manufacturers of medical devices seeking market clearance in the U.S.
2. Companies introducing a new device that is substantially equivalent to an existing one.
3. Organizations involved in the development of new medical technologies.
4. Regulatory affairs professionals managing device submissions.

People Also Ask about

What is the 501k process?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What does 501k clearance mean?

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.

How long does 501k approval take?

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.

What is the 510k process?

Domestic manufacturers introducing a device to the U.S. market; Finished device manufacturers must submit a 510(k) if they manufacture a device ing to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices.

How long does it take to get 510k approval?

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 the three types of 510k?

FDA Clearance. A 510(k) is a premarket submission made to the FDA. It is called a 510(k) because it refers to that section of the Food, Drug and Cosmetic Act. It is the regulatory pathway mostly utilized for Class II devices that hope to be substantially equivalent to another device which is currently legally marketed.

For pdfFiller’s FAQs

What is 510(k) Summary of Safety and Effectiveness Information?

The 510(k) Summary of Safety and Effectiveness Information is a document submitted to the FDA by manufacturers for medical devices to demonstrate that the device is safe and effective, and substantially equivalent to a legally marketed device.

Who is required to file 510(k) Summary of Safety and Effectiveness Information?

Any medical device manufacturer that wishes to market a medical device in the United States must submit a 510(k) Summary if the device is not exempt from premarket notification requirements.

How to fill out 510(k) Summary of Safety and Effectiveness Information?

To fill out a 510(k) Summary, manufacturers need to provide detailed information about the device, including its intended use, technological characteristics, performance data, labeling, and comparisons to predicate devices.

What is the purpose of 510(k) Summary of Safety and Effectiveness Information?

The purpose of the 510(k) Summary is to demonstrate that the new device is as safe and effective as a device already on the market, ensuring patient safety and compliance with regulatory standards.

What information must be reported on 510(k) Summary of Safety and Effectiveness Information?

The information that must be reported includes device identification, intended use, technological characteristics, performance data, and any labeling that accompanies the device.