This form is to report an allegation of regulatory misconduct, a claim that a medical device/electronic product, manufacturer or individuals marketing medical devices/ electronic products, may be doing so in a manner that violates the law.  Submitting an allegation is voluntary and the form does not have to be complete in order for the allegation to be reviewed.

Please include as much of the following information as possible to help the FDA assess the allegation you are reporting:

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Name of the company for which you are submitting an allegation:

Telephone number of the company:

Address of the company: Company Street Address

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* Name and model (if applicable) of the Medical Device(s) / Electronic Products in question:

Lot numbers / serial numbers / part numbers: Lot, Serial, or Part Numbers

* Detailed description of the allegation with any available supporting documentation: Description

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Your Name:

Your Email:

Submit