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Get the free Revised 510(k) Summary - K163190

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DEPARTMENT OF HEALTH & HUMAN SERVICESPublic Health Serviced and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66G609 Silver Spring, MD 209930002December 12, 2016 Income
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01
Begin by reviewing the previous 510k summary to understand the changes that need to be addressed.
02
Ensure that you have the necessary documents and information, such as the device information, indications for use, and intended users.
03
Start by providing a clear and concise summary of the changes made to the device, including any modifications to its design, materials, or manufacturing process.
04
Include information on any updated performance testing or clinical studies that have been conducted on the device.
05
Provide a detailed comparison between the previous and revised versions of the device, highlighting the improvements or changes made.
06
Ensure that the revised 510k summary is coherent and organized, with clear headings, subheadings, and bulleted lists to enhance readability.
07
Double-check the accuracy of the information provided in the summary and make any necessary revisions or corrections before finalizing it.
08
Submit the revised 510k summary along with any supporting documentation to the relevant regulatory authorities for review and approval.

Who needs revised 510k summary?

01
Medical device manufacturers who have made significant changes or modifications to their previously cleared devices.
02
Manufacturers who are seeking clearance from the FDA to market their modified devices.
03
Regulatory affairs professionals responsible for preparing and submitting 510k applications for modified medical devices.
04
Quality assurance personnel who need to ensure compliance with FDA regulations regarding revised 510k summaries.
05
Healthcare professionals who require accurate and up-to-date information on the modifications made to a medical device before using it on patients.
06
Regulatory authorities and agencies responsible for evaluating and approving revised 510k summaries and modified medical devices.
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Revised 510k summary is a document submitted to the FDA for medical device clearance or approval, containing updated information or modifications to an existing 510k submission.
Manufacturers of medical devices seeking clearance or approval from the FDA are required to file revised 510k summaries.
Revised 510k summaries should be filled out with updated information, modifications, and any changes made to the original 510k submission.
The purpose of revised 510k summary is to provide the FDA with updated information on a medical device, ensuring its safety and effectiveness.
Revised 510k summary must report any changes, modifications, and updated information related to the medical device being submitted for clearance or approval.
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