March 23, 2023

Regulatory Misconduct Allegations

Making unsubstantiated claims about one’s device, promoting off-label uses, and selling medical devices with uncleared/unapproved features are examples of what the U.S. FDA calls “regulatory misconduct”.  Specifically, regulatory misconduct is when a medical device manufacturer or other individuals marketing medical devices are doing so in a manner that violates the law.  The U.S. FDA has a mechanism for receiving complaints (allegations) of such misconduct.  I’ve lodged such complaints on behalf of clients, or helped them do so themselves.  Here’s an FDA webpage about how to formally lodge an allegation of regulatory misconduct.

In the end, FDA’s intervention (if any comes at all) will be driven commensurate with risk amidst FDA’s strained resources.  It seems that only in the riskiest of situations will FDA react swiftly; otherwise my experience is that FDA might just move the alleged violative firm higher in FDA’s routine inspection queue, or it may even seem that nothing has been done at all… Transparency from the FDA to know exactly what FDA has been done is still governed by the FOIA, so the process is one that takes time.  Further details on these dynamics are included in the foregoing link.

Regarding reporting to European Competent Authorities (CA), I suggest contacting the affected medical device CA(s) for direction on how each would have you report allegations of regulatory misconduct.