Get the free 510 (k) Statement - accessdata.fda.gov
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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 209930002May 9, 2016InnoBioSurg Co.,
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How to fill out 510 k statement
How to fill out 510 k statement
01
Obtain the necessary forms from the FDA website.
02
Complete the application form, including your contact information and device details.
03
Provide a detailed description of the device and its intended use.
04
Include any previous testing or clinical data related to the device.
05
Submit any relevant performance data or comparison to similar devices on the market.
06
Complete the sections on biocompatibility, sterilization, and risk analysis.
07
Provide information on labeling, packaging, and any relevant instructions for use.
08
Finally, submit the completed form to the FDA along with any required fees.
Who needs 510 k statement?
01
Manufacturers of medical devices who are introducing a new device to the market or making significant changes to an existing device.
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What is 510 k statement?
The 510(k) statement is a premarket submission made to the FDA to demonstrate that a medical device is safe and effective and is substantially equivalent to a legally marketed device.
Who is required to file 510 k statement?
Manufacturers of medical devices intending to market a device that is not exempt are required to file a 510(k) statement with the FDA.
How to fill out 510 k statement?
To fill out a 510(k), the applicant must provide information including device description, intended use, technological characteristics, and performance data, typically following the FDA's guidance on format and content.
What is the purpose of 510 k statement?
The purpose of the 510(k) statement is to demonstrate that a new medical device is as safe and effective as a similar device that is already legally marketed.
What information must be reported on 510 k statement?
The information must include device identification, intended use, technological comparison to predicate devices, safety and effectiveness data, and manufacturing details.
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