Earlier this week, the FDA launched a new webpage to simplify the process of reporting violations of the law by medical device manufacturers and individuals marketing medical devices. Unlike the MedWatch system for reporting adverse events and problems relating to products already in the field, the new webpage aims to capture reports of process violations relating to quality systems, regulatory compliance and marketing activities. Reporters can choose to submit information anonymously through email or regular mail. By launching the new webpage, the FDA hopes to identify potential risks to patients of which they would otherwise be unaware, and determine when further investigation is warranted.

What Types of Conduct Concern FDA?

  • Examples of regulatory misconduct cited by FDA include:
  • Failure to register and list a medical device
  • Marketing uncleared or unapproved devices
  • Failure to follow quality systems requirements
  • Promoting devices outside of the cleared or approved indications
  • Failure to submit Medical Device Reports for device-related safety concerns
  • Devices or manufacturing processes do not meet their design and manufacturing responsibilities
  • Importing medical devices that do not meet legal requirements for admission to the U.S.
  • Forging or falsifying an export certificate by a third party in order to bring medical devices into the U.S.
  • Failure to register and list medical device products with the FDA
  • Hiding information from or falsifying documents given to the FDA

Serious adverse events, product quality problems, therapeutic inequivalence/failure, and product use errors associated with FDA-regulated products still should be reported through the MedWatch program.

What Can Happen if FDA Confirms the Allegations?

Allegations will be reviewed by the Center for Devices and Radiological Health (CDRH) and prioritized based on the level of potential risk to patients. The FDA will then make a determination if further investigation is warranted. Potential FDA actions include Warning Letters, inspections of the manufacturing facility, requests for device recall, requests for additional information from the firm and monitoring the allegation to determine if action is needed.

What This Means for Firms

The new reporting process means that firms, as always, must stay vigilant in overseeing compliance with respect to their quality, regulatory and marketing activities or risk enforcement action. The extent to which FDA will receive, or initiate enforcement action based upon, reports of alleged regulatory misconduct remains to be seen. However, the new process undeniably expands the FDA enforcement landscape. Accordingly, firms would be well served by re-visiting existing compliance best practices, including, for example, conducting periodic audits, maintaining good documentation of the scientific and legal rationale underlying decisions, and monitoring sales activities.