Kate T. Klaus, Esq. | Staff Attorney, Medmarc Loss Control
Earlier this week, FDA launched a new program in which individuals can report, directly to FDA’s Center for Devices and Radiological Health, allegations of regulatory misconduct on the part of medical device manufacturers and marketers. The agency understands very well the vast reach of the medical device industry, but its limited resources have allowed bad actors to market their products while attempting to remain below FDA’s radar. In addition to creating potential risks for patient safety, this flouting of regulations has long been a source of frustration for medical device companies that do operate within the bounds of the law and feel unfairly disadvantaged when competitors skirt the rules.
Examples of reportable misconduct include:
- Advertising or promoting a device beyond the bounds of its indications for use;
- Marketing a device without the necessary clearance or approval;
- Failing to implement or comply with necessary Quality System requirements;
- Importing devices that do not meet U.S. legal criteria;
- Failing to register and list with FDA, thus preventing FDA from properly overseeing operations; and
- Knowingly deceiving FDA in some fashion, whether falsifying documents or hiding information.
Reports are accepted through the FDA webpage, as well as by mail and email. While FDA encourages reporters to include their name and contact information in the event that additional information is required, reports can be filed anonymously. FDA will review the reports, evaluate potential risks to public safety, and determine the appropriate intervention or enforcement action.
What is the takeaway for medical device firms? For those already operating in compliance with FDA regulations, there should not be a burdensome impact. Even if FDA chooses to investigate an allegation, frivolous claims will likely be dispensed with easily when met with strong quality systems and thorough recordkeeping practices. However, for those firms attempting to fly beneath FDA’s radar, they may find themselves on the receiving end of a Warning Letter in short order. Your competitors have been watching your practices for years, but FDA has now empowered them to act.
For more information on compliance with FDA regulations, please see our Life Sciences Guidebook, available for sale on Amazon.