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510(k) Summary 18 2011IntroductionAccording to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence.
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How to fill out substantial equivalence
How to fill out substantial equivalence
01
To fill out substantial equivalence, follow these steps:
02
Begin by clearly identifying the device that you are comparing your device to.
03
Collect and organize all the necessary information about your device, including its design, components, materials, and intended use.
04
Compare each aspect of your device to the reference device, noting any differences.
05
Assess the impact of these differences on the device's safety and effectiveness.
06
Clearly document your findings and provide supporting evidence.
07
Prepare a summary report that highlights the similarities and differences between your device and the reference device.
08
Submit the substantial equivalence report to the appropriate regulatory authority for review and evaluation.
Who needs substantial equivalence?
01
Substantial equivalence is required for manufacturers or developers of medical devices.
02
It is necessary for companies seeking regulatory approval or clearance for their medical devices.
03
Regulatory authorities use substantial equivalence to determine if a new device is as safe and effective as a predicate device already on the market.
04
Therefore, anyone who wishes to market a new medical device needs to establish substantial equivalence.
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What is substantial equivalence?
Substantial equivalence is a comparison between a new product and a predicate product to determine if they are the same in terms of risk and performance.
Who is required to file substantial equivalence?
Manufacturers of new tobacco products in the US are required to file substantial equivalence.
How to fill out substantial equivalence?
To fill out substantial equivalence, manufacturers need to provide documentation comparing their product to a predicate product.
What is the purpose of substantial equivalence?
The purpose of substantial equivalence is to assess if a new tobacco product is similar to an already marketed product in terms of risk and performance.
What information must be reported on substantial equivalence?
Manufacturers must report information such as ingredients, design, packaging, and intended use of the product on substantial equivalence.
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