Reporting Allegations of Regulatory Misconduct - Intro Screen

Reporting Allegations of Regulatory Misconduct | FDA

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

An allegation of regulatory misconduct is a claim that a medical device manufacturer
or individuals marketing medical devices may be doing so in a manner that violates
the law. Reporting these allegations can help make the FDA aware of regulatory
concerns it may not learn of otherwise. This information can help the FDA identify the
potential risks to patients and determine whether further investigation is warranted,
as well as any steps needed to address or correct a potential violation.
Anyone may file a complaint reporting an allegation of regulatory misconduct. The
FDA encourages people submitting allegations to include supporting information and
contact information in case additional information is needed for the FDA to
understand the allegation and act on the report; however you can choose to submit a
report anonymously. The FDA will not share your identity or contact information with
anyone outside the FDA unless required to do so by law, regulation, or court order.

What kinds of allegations can be reported?
Allegations of regulatory misconduct may include failure to register and list a medical
device, marketing uncleared or unapproved products, failure to follow quality system
requirements, or misleading promotion. The table below provides some examples of
the kind of allegations the FDA has received:

Examples of allegations
• Promotion or advertising of a device outside the FDA-cleared or approved
indications for use.
• A device manufacturer fails to submit required reports (/medicaldevices/medical-device-safety/medical-device-reporting-mdr-how-reportmedical-device-problems) to the FDA for device-related safety concerns, and/or
is not conducting required follow up investigations per the regulatory
requirements.

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• A company's medical devices or manufacturing processes do not meet their
design and manufacturing responsibilities.
• Marketing a medical device without the appropriate FDA clearance (510(k)) or
approval (PMA).
• A manufacturer imports medical devices into the United States that do not meet
legal requirements for admission to the U.S.
• A third party outside the medical device company forges or falsifies an export
certificate to bring medical devices into the U.S.
• A company fails to register and list their medical device products with the FDA,
preventing the FDA from having required information about a device on the
market.
• A manufacturer knowingly deceives the FDA. For example, the manufacturer
hides information from the FDA, or falsifies documents, etc. given to the FDA.

How do I submit an allegation about a medical device manufacturer to
the FDA?
You can submit an allegation through the Allegations of Regulatory Misconduct Form
(/medical-devices/reporting-allegations-regulatory-misconduct/allegationsregulatory-misconduct-form), by email, or by regular mail.
Email:
[email protected] (mailto:[email protected])
Regular Mail:
Attention: Allegations of Regulatory Misconduct Team
Office of Regulatory Programs
Center for Devices and Radiological Health
Food and Drug Administration
WO Bldg. 66 RM 1523
10903 New Hampshire Ave
Silver Spring, MD 20993

What information should I include when reporting an allegation of
regulatory misconduct?
The following information helps the FDA assess an allegation:
• Medical device(s) in question, including:

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◦ Name of the company
◦ Address and telephone number of the company, if known
◦ Name of the device and model (if applicable)
◦ Lot numbers/serial numbers/part numbers
◦ Unique Device Identifier (UDI), if known
◦ Recall numbers
• Detailed description of the allegation with any available supporting
documentation
To report serious adverse reactions, product quality problems, therapeutic
inequivalence/failure, and product use errors associated with FDA-regulated drugs,
biologic products, medical devices, dietary supplements, infant formula, and
cosmetics, visit the MedWatch adverse event reporting webpage (/safety/medwatchfda-safety-information-and-adverse-event-reporting-program/reporting-seriousproblems-fda). For questions about other medical device topics, please contact the
CDRH Division of Industry and Consumer Education (/medical-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-andconsumer-education-dice).
If you have questions about submitting an allegation, you may contact the Allegations
of Regulatory Misconduct Staff by phone at (240)402-7675 or by email at
[email protected] (mailto:[email protected]).

What happens to allegations of regulatory misconduct submitted to the
FDA?
Allegations of regulatory misconduct related to medical devices are reviewed by the
Center for Devices and Radiological Health (CDRH). CDRH prioritizes the review of
allegations based on the level of potential risks, within the context of an overall
benefit-risk profile, to patients. There are different processes based on the type of
allegation and the completeness of the information submitted. The following are the
general steps CDRH takes after receiving an allegation of regulatory misconduct:
1. If contact information is provided, CDRH sends an acknowledgement letter to
the submitter which includes an FDA-assigned identification number for the
allegation report. This number is used in all follow-up communication to ensure
that the report information is filed together.

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2. CDRH assesses the allegation and determines the potential risk to patients, and
CDRH will investigate further if warranted. After our assessment, we take
appropriate action, which could include:
◦ Regulatory actions such as sending a warning letter to the medical device
firm, conducting an inspection of the manufacturing facility, or requesting
a device recall.
◦ Contacting the individual, firm or medical device manufacturer for
additional information.
◦ Monitoring the allegation using additional sources of reported information
(e.g. medical device reports (MDRs), new complaints, inspection reports)
to determine any action needed.

How can I find out the outcome of an allegation submitted to the FDA?
Requests for records of completed investigations can be submitted pursuant to the
Freedom of Information Act (FOIA). Please note that FOIA does not require agencies
to create new records or to conduct research, analyze data, or answer questions
submitted as FOIA requests for records.
Information about how the CDRH Division of Information Disclosure implements the
requirements of FOIA is available at CDRH FOIA: How to get records from CDRH
(/about-fda/center-devices-and-radiological-health/cdrh-foia-how-get-records-cdrh).
Please note that investigations of allegations of regulatory misconduct can be
complicated and take time. If you plan to submit a FOIA request (/regulatoryinformation/freedom-information/how-make-foia-request), we recommend waiting at
least 180 days after submitting allegations to the FDA before submitting a FOIA
request for related records.

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