Today the FDA has announced the establishment of a website through which anyone can report an allegation of regulatory misconduct. Examples of allegations include promoting or advertising a device outside of the FDA-approved indications for use; importing a device into the United States without it meeting legal requirements; falsifying an export certificate to bring a device into the United States; failing to register and list a medical device with the FDA; and intentionally deceiving the FDA.
“Reporting allegations can help make the FDA aware of regulatory concerns it may not learn of otherwise,” according to an agency release. “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.”
An instance of regulatory misconduct can be reported by filling out this form on the FDA’s website. Although the agency is encouraging that allegations include supporting information and contact information, people can also submit a report anonymously. The agency states that it will not share the identity or contact information with anyone outside of the FDA unless required by law or court order.
Related Articles
-
Effective February 7, the agency will conduct inspections across all commodities, as well as mission-critical foreign and domestic inspections.
-
The CERSI program was established to foster robust and innovative approaches to advance regulatory science through collaborative interactions with FDA scientific experts.
-
As of June 1, 2022, the Center for Devices and Radiological Health plans to accept all non-COVID in vitro diagnostic (IVD) pre-submissions.
-
The FDA CDRH is seeking input from industry and the public on expanding access to home use medical technologies. The comment period closes on August 30, 2023.
