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Brother Diagnostics, Inc. Traditional Premarket Notification 510(k) Submission Rapider Oral Fluid Assay for Opiates JAN 2 4 2014 510(k) Summary for the Rapider Oral Fluid Assay for OPIATES This summary

How to fill out traditional premarket notification 510k

How to fill out traditional premarket notification 510k?

1. Gather the necessary information: Start by collecting all the relevant documents and information required for the premarket notification 510k. This includes the medical device description, intended use, indications for use, labeling, and any supporting data or clinical studies.
2. Identify the predicate device: Determine the predicate device that your medical device will be compared to for the premarket notification. This will involve researching and identifying a legally marketed device with similar intended use and technological characteristics to serve as a benchmark.
3. Prepare the 510k application: Create the 510k application, which is typically comprised of several sections. These sections include administrative, device description, substantial equivalence, labeling, and clinical data (if applicable). Follow the specific format and structure as required by the regulatory authority.
4. Complete the administrative section: Fill out the administrative section of the 510k application, which includes general information about the submitter, manufacturer, and contact details. Ensure accuracy and provide any additional requested information, such as previous 510k submissions or any provisional patent applications.
5. Provide device description and intended use: Clearly describe the medical device, its components, and how it functions. Include details about the device's materials, design, dimensions, and any unique features. Clearly outline the intended use and indications for use of the medical device.
6. Establish substantial equivalence: Explain how the medical device is substantially equivalent to the predicate device identified earlier. Provide a detailed comparison of the device's technological characteristics, safety, and effectiveness to demonstrate that it is as safe and effective as the predicate device.
7. Develop labeling: Create the labeling for the medical device, including the instructions for use, warnings, contraindications, and any necessary precautions. Ensure that the labeling is clear, concise, and complies with the regulatory requirements for proper device usage and handling.
8. Include clinical data (if applicable): If your medical device requires clinical data to support its safety and effectiveness, provide any clinical study reports or data generated during the testing phase. Make sure to follow the regulatory guidelines for conducting clinical trials and ensure that the data is relevant and scientifically sound.

Who needs traditional premarket notification 510k?

1. Manufacturers of class II or class III medical devices in the United States need to submit a traditional premarket notification 510k. This includes companies that are introducing a new medical device to the market or making technologically significant modifications to an existing device.
2. Importers who are responsible for placing a medical device on the U.S. market also need to adhere to the premarket notification requirements. Even if the device is manufactured outside the United States, the importer must ensure compliance with the regulations and submit the required documentation.
3. Regulatory professionals, consultants, and legal representatives involved in the medical device industry may also require knowledge and understanding of the traditional premarket notification 510k process. Their expertise can assist manufacturers and importers in successfully navigating the regulatory pathway and ensuring compliance.

For pdfFiller’s FAQs

What is traditional premarket notification 510k?

Traditional premarket notification 510k is a submission made to the FDA to demonstrate that the medical device to be marketed is as safe and effective as a device which is already on the market (predicate device).

Who is required to file traditional premarket notification 510k?

Manufacturers of medical devices are required to file traditional premarket notification 510k.

How to fill out traditional premarket notification 510k?

Traditional premarket notification 510k must be filled out with detailed information about the device, its intended use, technological characteristics, and comparison with the predicate device.

What is the purpose of traditional premarket notification 510k?

The purpose of traditional premarket notification 510k is to demonstrate that the new medical device is substantially equivalent to a predicate device and does not pose a significant risk to patients.

What information must be reported on traditional premarket notification 510k?

Information such as device description, indications for use, performance data, material composition, and labeling must be reported on traditional premarket notification 510k.

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