Get the free 510k Summary fl2 019 - Food and Drug Administration - accessdata fda

510(k) Summary fl2 019 1. SuBMirrER51O(K) HOLDER Media, LLC 4 Fairfield Blvd. Wallingford, CT 06492 Contact Person: Sheila K Wallis Telephone: 2032940000 308 Date Prepared: March 4, 2013 2. MAR 20

How to fill out 510k summary fl2 019

How to fill out 510k summary fl2 019?

1. Start by understanding the purpose of the 510k summary fl2 019. It is a document required by the U.S. Food and Drug Administration (FDA) for medical device manufacturers to demonstrate that their device is substantially equivalent to a legally marketed device.
2. Begin by providing the necessary information about the device. This includes the device's name, manufacturer, intended use, indications for use, and any special features or components.
3. Next, describe the technological characteristics of the device. This should include information about the device's design, composition, materials used, and any unique features or functions.
4. Provide a detailed summary of any performance testing that has been conducted on the device. This may include laboratory testing, animal studies, or clinical trials. Include information about the study design, sample size, methodology, and any relevant results or conclusions.
5. If applicable, include information about any prior versions or models of the device that have been cleared by the FDA. This helps to establish the device's lineage and history of safe and effective use.
6. Finally, include any additional information or documentation that may be required by the FDA. This could include labeling, instructions for use, or any other relevant supporting documents.
7. Review the completed 510k summary fl2 019 to ensure all required information has been provided accurately and comprehensively. Make any necessary edits or revisions before submitting it to the FDA for review.

Who needs 510k summary fl2 019?

1. Medical device manufacturers who intend to market or sell their devices in the United States need to submit a 510k summary fl2 019 to the FDA for review and clearance.
2. Medical device regulatory professionals responsible for ensuring compliance with FDA regulations and obtaining market clearance for new devices may need to prepare the 510k summary fl2 019.
3. The FDA itself requires the 510k summary fl2 019 for evaluating the substantial equivalence of a medical device to determine its safety and effectiveness before granting market clearance.

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What is 510k summary fl2 019?

The 510k summary fl2 019 is a summary report submitted to the FDA to demonstrate that a new medical device is substantially equivalent to existing devices.

Who is required to file 510k summary fl2 019?

Manufacturers of medical devices seeking FDA clearance are required to file the 510k summary fl2 019.

How to fill out 510k summary fl2 019?

To fill out the 510k summary fl2 019, manufacturers must provide detailed information about the new device, predicate devices, testing results, and intended use.

What is the purpose of 510k summary fl2 019?

The purpose of the 510k summary fl2 019 is to demonstrate that a new medical device is safe and effective for use by comparing it to similar devices already on the market.

What information must be reported on 510k summary fl2 019?

The 510k summary fl2 019 must include information on device description, intended use, technological characteristics, testing results, and comparison to predicate devices.