![]() II. What Is the Process For Obtaining a Formal Classification Determination for a Product? To discuss an alternative approach, contact the FDA office responsible for this guidance listed above. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. ![]() It does not establish any rights for any person and is not binding on FDA or the public. This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic.
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