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The document provides a summary of the 510(k) premarket notification for the BodyFIX System, detailing device specifications, intended use, equivalence to existing devices, and regulatory compliance

How to fill out 510k summary bodyfix system

How to fill out 510(k) Summary BodyFIX System

1. Identify the device - Clearly state that the device is the BodyFIX System.
2. Submit required company information - Provide the name, address, and contact information of the manufacturer.
3. Describe the device - Include a detailed description of the BodyFIX System and its intended use.
4. Summarize the intended use - Explain how the device is intended to be used and the patient population it serves.
5. Provide a summary of the technological characteristics - Outline the materials, design, and specifications of the BodyFIX System.
6. Comparison with predicate device - Identify and describe a legally marketed predicate device that demonstrates substantial equivalence.
7. Offer a summary of safety and effectiveness data - Include non-clinical as well as clinical data supporting safety and performance.
8. Include labeling information - Provide copies of the proposed labels, instructions for use, and patient information.
9. Submit the 510(k) summary - Compile all of the above information into the 510(k) summary format as specified by the FDA.

Who needs 510(k) Summary BodyFIX System?

1. Medical device manufacturers planning to market the BodyFIX System.
2. Healthcare professionals evaluating the safety and effectiveness of the BodyFIX System.
3. Regulatory bodies needing to review the device for compliance with safety regulations.
4. Patients who may rely on the BodyFIX System for their treatment.

People Also Ask about

What is the FDA 510k 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.

What is 510k summary report?

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) that is not subject to premarket approval.

How long does FDA 510 K approval take?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

What is the 510k clearance process?

The 510k clearance process is the most common pre-market pathway used by medical device companies to legally sell products in the US, as data from the FDA shows that: 35% of medical devices are in Class I, the lowest risk class, as they present minimal potential for harm to the end user.

What is 501k approval?

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 FDA clearance take?

The 510(k) clearance process involves a comprehensive review of safety and performance data for the device, which may include scientific, non-clinical, and clinical data, as appropriate, to determine if a new device is substantially equivalent to a device that is already on the market (that is, a predicate device).

What is the 5 10k approval process?

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 510k summary?

Once the FDA have received your submission, the FDA will officially start the clock on your decision timeline. At the time of writing the FDA states that a traditional 510(k) decision should be provided within 90 days.

How long will it take my 510 K to be cleared by the US FDA?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

For pdfFiller’s FAQs

What is 510(k) Summary BodyFIX System?

The 510(k) Summary BodyFIX System is a premarket submission made to the FDA that demonstrates that a medical device is safe and effective and is substantially equivalent to an already legally marketed device.

Who is required to file 510(k) Summary BodyFIX System?

Manufacturers of medical devices that wish to market their products in the United States and believe their devices are substantially equivalent to an already marketed device are required to file a 510(k) Summary.

How to fill out 510(k) Summary BodyFIX System?

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

What is the purpose of 510(k) Summary BodyFIX System?

The purpose of the 510(k) Summary is to ensure that medical devices meet FDA regulations and standards for safety and effectiveness before they are marketed.

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

The 510(k) Summary must include device description, intended use, the predicate device's identification, performance testing data, labeling, and any other relevant information to establish substantial equivalence.