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This document summarizes the 510(k) premarket notification for the Morce Scope Set 8970, detailing its intended use, technological characteristics, and the substantial equivalence to existing legally

How to fill out 1 130 51 0k

How to fill out 1 13.0 51 0(k) Summary of Safety and Effectiveness

1. Gather all relevant data regarding the medical device or product being submitted.
2. Start with a clear and concise introduction describing the device and its intended use.
3. Provide a brief summary of the existing safe and effective uses of similar devices.
4. List the specific safety and effectiveness data you have collected from preclinical and clinical studies.
5. Include a comparison with existing products in the market, highlighting the similarities and differences.
6. Ensure all data presented follows the format required by the FDA 510(k) guidelines.
7. Review and verify that all sections are complete and accurate before submission.

Who needs 1 13.0 51 0(k) Summary of Safety and Effectiveness?

1. Medical device manufacturers seeking FDA clearance for their products.
2. Regulatory affairs professionals who manage submissions to the FDA.
3. Healthcare providers interested in understanding the safety and effectiveness of new devices.
4. Investors assessing the viability of a medical device company based on its products.

People Also Ask about

What are the three types of 510k?

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.

Is 510k safe and effective?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

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.

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.

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.

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 FDA summary?

Overview of Section 510(k) This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories. Thus, "new" devices (not in commercial distribution prior to May 28, 1976) that have not been classified can be properly identified.

For pdfFiller’s FAQs

What is 1 13.0 51 0(k) Summary of Safety and Effectiveness?

The 1 13.0 51 0(k) Summary of Safety and Effectiveness is a document required by the FDA that provides a brief overview of the safety and effectiveness of a medical device seeking premarket notification. It summarizes the device's intended use, technological characteristics, clinical data, and performance.

Who is required to file 1 13.0 51 0(k) Summary of Safety and Effectiveness?

Manufacturers of medical devices that are seeking premarket notification (510(k)) to market their products in the United States are required to file the 1 13.0 51 0(k) Summary of Safety and Effectiveness.

How to fill out 1 13.0 51 0(k) Summary of Safety and Effectiveness?

To fill out the 1 13.0 51 0(k) Summary of Safety and Effectiveness, manufacturers must provide specified information including device description, intended use, substantial equivalence claims, and results of any safety and effectiveness testing that was conducted.

What is the purpose of 1 13.0 51 0(k) Summary of Safety and Effectiveness?

The purpose of the 1 13.0 51 0(k) Summary of Safety and Effectiveness is to inform the FDA and the public about the safety and effectiveness of a new medical device in comparison with existing products, thus facilitating regulatory oversight.

What information must be reported on 1 13.0 51 0(k) Summary of Safety and Effectiveness?

The 1 13.0 51 0(k) Summary of Safety and Effectiveness must report information including the device name, intended use, technological characteristics, comparisons to predicate devices, performance testing results, and any applicable clinical data.