New FDA Website for Reporting Allegations of Regulatory Misconduct

PUBLISHED: Oct 24, 2016
Source: Food and Drug Administration

The US Food and Drug Administration (FDA) has launched a new webpage, Allegations of Regulatory Misconduct. 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.

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.

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.

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