For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead.
Unidentified tipsters — from disgruntled former employees to plaintiffs’ attorneys — may now use a simple internet form to allege that a medical device manufacturer violated Food and Drug Administration (FDA) regulations. On October 21, FDA’s Center for Devices and Radiological Health (CDRH) unveiled a new website for reporting allegations of regulatory misconduct. The website expressly solicits reports of violations of FDA regulations, rather than reports of alleged problems with the use of a device.
CDRH previously announced that one of its 2016-2017 strategic priorities is to “[p]romote a culture of quality and organizational excellence.” The new website continues the work CDRH was already doing — collecting reports of regulatory violations and, where appropriate, initiating enforcement actions. For device manufacturers and sellers, the website represents another source of information to monitor for possible challenges ahead.
The CDRH website allows anyone to make an anonymous allegation of regulatory misconduct. We expect to see reports coming from competitors, dissatisfied personnel, former consultants and anyone with an axe to grind, including lawyers who are bringing or investigating legal claims. CDRH lists examples of potential regulatory violations that may be reported, including:
failure to submit required safety reports
failure to follow quality system requirements
marketing uncleared or unapproved products
failure to register and list a medical device
failure to follow import and export regulations.
CDRH also says that allegations could involve a manufacturer that “knowingly deceives the FDA.”1
Reporting parties may submit a description of the alleged conduct via a one-page “Allegations of Regulatory Misconduct” form online. CDRH even says that it will review incomplete forms.2
CDRH will prioritize reports based on the nature of the allegations and risks posed to patients. After reviewing a report, CDRH could take enforcement action, ask a company for more information, or monitor the allegation via medical device reports (MDRs), new complaints, inspections, etc.3
The website is not for reporting possible device-related adverse events. Those should continue to be reported via the MedWatch adverse event reporting website.
What Effect Will CDRH’s Website Have on Enforcement Actions?
CDRH’s receipt of claims of regulatory misconduct is not new. In 2012 and 2013, CDRH’s Allegations of Regulatory Misconduct Branch received 558 and 682 reports of misconduct, respectively.4 Allegations related most frequently to promotion and advertising, quality systems, and unapproved or uncleared devices. In 2012, the claims resulted in 24 warning letters and, in 2013, 12 warning letters.5 These numbers suggest that CDRH seldom verifies spontaneous reports of regulatory misconduct. But CDRH identified regulatory violations through other means (including its own monitoring activities), issuing 210 warning letters in 20126 and 217 warning letters in 2013.7
FDA recognizes the limitations of passive surveillance systems. FDA’s MAUDE database, which maintains MDRs of possible device-related adverse events, cautions users that the database may contain “incomplete, inaccurate, untimely, unverified, or biased data.”8 The same may be said of CDRH’s website for collecting allegations of regulatory misconduct.
Takeaways for Manufacturers
Requests to FDA for records of completed investigations regarding allegations of regulatory misconduct may be made through the Freedom of Information Act.9 Manufacturers should consider making regular and ongoing requests to monitor what is reported. This will allow manufacturers to know what information is available for plaintiffs’ attorneys to use to potentially disparage or take action against a company. And, where manufacturers face litigation, they may monitor for litigation-stimulated reports. Despite the potential risks that such information presents, manufacturers may also gain insight into how CDRH makes regulatory decisions and decides when to take action.