FDA’s new Draft Guidance reviews manufacturer reporting requirements, written policies and procedures, recordkeeping and public disclosure of MDRs, and specific situations where a report may or may not be required. The Draft Guidance will supersede the March 1997 Guidance. Below are four key points:

  1. Reportable Occurrences including User Error. Manufacturers must report events that reasonably suggest one of their marketed devices may have caused or contributed to a death or serious injury. “Caused or contributed” is defined to include:
  • device failure;
  • malfunction;
  • improper or inadequate design;
  • manufacturer concerns;
  • labeling concerns; or
  • user error.

“User error” means:

  • a device-related error; or
  • a mistake made by the person using the device, especially including a healthcare practitioner.

FDA believes user errors can reflect problems with device labeling, the user interface or other aspects of device design, and must be reported.

  1. Reporting Deadlines. MDR reportable events generally must be submitted to FDA within 30 calendar days after the day the manufacturer becomes aware of the event. However, a 5-day report is required when:
  • a manufacturer knows of an adverse event that necessitates remedial action to prevent an unreasonable risk of substantial harm to public health; or
  • FDA requested the submission of 5-day reports.
  1.  Manufacturer and Employee Awareness. FDA considers a manufacturer to be aware of a reportable event whenever any employee becomes aware of information that reasonably suggests a manufacturer must submit a 30-day report or a 5-day report that the FDA has requested. Further, for 5-day reports regarding an unreasonable risk of substantial harm to the public health, a manufacturer becomes aware of a reportable event when any of the manufacturer’s employees with management or supervisory responsibilities over persons with regulatory, scientific or technical responsibilities, or whose duties relate to the collection and reporting of adverse events become aware of any information necessitating remedial action.
  2. Policies and Procedures. Manufacturers must develop, maintain and implement written policies and procedures that cover all the requirements of the MDR regulation. The procedures must include internal systems that provide for
  • timely and effective identification, communication and evaluation of events that may be subject to MDR requirements;
  • a standardized review process for determining whether or not an event is an MDR reportable event; or
  • timely transmission of complete reports to the FDA.