Electronic Submission of Voluntary Allegations to CDRH

Allegations of Regulatory Misconduct Form | FDA

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Allegations of Regulatory Misconduct Form
OMB control number: 0910-0769
Approval Expiration Date: 11/30/2020

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:

Name of the company for which you are submitting an allegation:
Company Name
Telephone number of the company:
Company Phone
Address of the company:
Company Street Address

* Name and model (if applicable) of the Medical Device(s) / Electronic Products in question:
Device / Electronic Product Name
Lot numbers / serial numbers / part numbers:
Lot, Serial, or Part Numbers

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

https://www.fda.gov/medical-devices/reporting-allegations-regulatory-misconduct/allegat... 10/15/2020

Allegations of Regulatory Misconduct Form | FDA

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Description

Your Name:
Your Name
Your Email:
Your Email
Submit

Clear Form

Please email any document attachments to CDRHDeviceAllegations@fda.hhs.gov
(mailto:CDRHDeviceAllegations@fda.hhs.gov). Please send attachments from your email address used
above.

https://www.fda.gov/medical-devices/reporting-allegations-regulatory-misconduct/allegat... 10/15/2020