The website is called Reporting Allegations of Regulatory Misconduct and it helps the FDA recall dangerous devices, identify safety hazards, and investigate regulatory violations they might not discover otherwise.
Anyone can file a complaint — even anonymously — but the FDA encourages contact information and as much supporting evidence as possible. Examples might include:
- Promoting a device for unapproved “off-label” uses
- Not reporting injuries or malfunctions
- Not investigating safety concerns or fixing defects
- Bad manufacturing
- Selling unapproved devices
- Importing illegal devices
- Hiding information from the FDA
- Falsifying documents
There are several ways to file a complaint. You can use an online form, email OCMedicalDeviceCo@fda.hhs.gov, or send regular mail to the following address:
ATTN: Allegations of Regulatory Misconduct Branch
Office of Compliance
Center for Devices and Radiological Health
Food and Drug Administration
WO Bldg. 66 RM 3523
10903 New Hampshire Ave
Silver Spring, MD 20993
The complaints are reviewed with priority given to the most serious safety threats to patients. Further enforcement may entail a warning letter, inspection of the manufacturing facility, or a recall of the device.
Medical devices include everything from Halloween contact lenses to cancer radiation machines. The United States is the global industry leader, with over 6,500 manufacturers and $150 billion in yearly sales.
The FDA may need all the help it can get. A recent investigation by the Star Tribune found that since 2005, the agency received over 300,000 medical device injury reports after the 30-day deadline and allowed “summary” reports that kept details confidential.
Source: Law360