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Submitting Comments to the FDA on Tobacco Deeming Regulations NATO is asking all association members, including retailers, wholesalers, and manufacturers, to submit comments to the FDA's Center for
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How to fill out comment request substantial equivalence

01
Gather all necessary information and documentation related to the product.
02
Fill out the comment request substantial equivalence form with accurate and detailed information.
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Clearly state the intended use of the product and provide supporting data if necessary.
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Submit the completed form to the relevant regulatory authority for review and approval.

Who needs comment request substantial equivalence?

01
Manufacturers or distributors of medical devices or products that are seeking approval or clearance for market authorization.

What is Comment Request; Substantial Equivalence Reports for ... - tobacco ucsf Form?

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Comment Request; Substantial Equivalence Reports for ... - tobacco ucsf template instructions

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Comment request substantial equivalence is a process by which a company submits a request to the regulatory authority to demonstrate that a new product is substantially equivalent to a predicate product already on the market.
Any company seeking to market a new product that is deemed to be a modified risk tobacco product is required to file a comment request substantial equivalence.
The company must provide detailed information about the new product and compare it to the predicate product in terms of ingredients, design, and manufacturing processes.
The purpose of comment request substantial equivalence is to demonstrate that the new product is similar enough to the predicate product to be considered safe and effective for consumers.
The company must report information about the design, ingredients, and manufacturing processes of the new product, as well as any data on health risks and benefits compared to the predicate product.
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