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Get 5 10(k) Summary - Fda
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How to fill out the 5 10(k) Summary - FDA online
Filing a 5 10(k) Summary with the FDA is an essential step in bringing a medical device to market. This guide provides a clear, step-by-step approach to accurately completing the 5 10(k) Summary online, ensuring your submission is thorough and compliant.
Follow the steps to effortlessly complete your 5 10(k) Summary.
- Press the ‘Get Form’ button to retrieve the form, making it available to fill out in your browser.
- Begin by completing the Administrative Device Information section. Provide the device name, common name, product code, device classification, and purpose of submission. Ensure all information is accurate and matches the device details.
- Fill in the Submitter information, including the company name, ER number, address, and contact details. Double-check for any typos or inaccuracies.
- Detail the Description of Device Modification. Describe the modifications made to the device clearly, highlighting any changes in design, labeling, or software.
- Indicate the Intended Use of the device. Clearly define the populations and settings in which the device will be used, along with any necessary qualifications of the users.
- Outline the Indications for Use, explaining how the device will assist in diagnosing or treating specific medical conditions.
- Discuss Substantial Equivalence by comparing your device to a previously cleared device. This should include a detailed discussion of similarities and any differences in features or use.
- Complete the Design Control Activities section, providing information about any validations and verifications performed on the device's design and functionality.
- Present the Performance Characteristics, detailing the results of any testing related to the device. Include precision, method comparison, and any interference studies performed.
- Finalize your submission by reviewing all sections for accuracy. Save changes, then select the options to download or print the form for your records before sharing it with the FDA.
Complete and submit your 5 10(k) Summary online to ensure your device reaches the market efficiently.
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). ... Legally marketed also means that the predicate cannot be one that is in violation of the FD&C Act.
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