In a notice dated Tuesday, March 8, 2011 (PDF), the FDA purports to clarify the requirements for reporting device malfunctions by device importers. Given that medical device reporting (MDR) is a key component of ongoing, post-market quality review for medical devices marketed in the U.S., we thought a brief summary, perchance a "clarification," of these requirements is in order.

Since October 1, 1993, device importers have been required to report certain device malfunctions. Entities serving as a medical device importer must report the following events under the MDR requirements:

  1. Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:
    1. Submit reports of device-related deaths or serious injuries to us and to the manufacturer; or
    2. Submit reports of device-related malfunctions to the manufacturer.

Which malfunctions must be reported? A malfunction means "the failure of a device to meet its performance specifications or otherwise perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the intended use for which the device is labeled or marketed." Not all malfunctions are reportable. A reportable malfunction is one where the importer determines that a death or serious injury would result from the malfunction if it were to recur.

When does an importer report a malfunction to the manufacturer? You must submit a report to the manufacturer as soon as practicable but no later than 30 calendar days after the day that you receive or otherwise become aware of information from any source. This includes information from facilities, individuals, or through your own research, testing, evaluation, servicing, or maintenance of one of the devices, that reasonably suggests that one of the devices has malfunctioned and that this device or a similar device that you market would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. The report must be on form FDA 3500A. The FDA requires that these reports be in English.

Does the device importer report a malfunction directly to the FDA? No. Unlike reports of death or serious injuries that go to the FDA and the manufacturer, these reports of malfunctions go only to the manufacturer.

What else must an importer do to comply with the MDR? In addition to the requirements to report a malfunction to the manufacturer within 30 days, an importer needs to establish procedures for the following:

  1. Internal systems that provide for identification and communication of adverse events, and a process for timely review and reporting
  2. Documentation and recordkeeping requirements for evaluation of adverse events and documentation of those events that are reported.

So, why is the FDA clarifying this now? Amendments to the Food, Drug, and Cosmetic Act in 2007 changed malfunction reporting requirements for class I devices and those class II devices that are not permanently implantable, life supporting, or life sustaining. The new statutory language passed in 2007 required that FDA identify certain class I devices and those class II devices that are not implantable that may be dangerous and require imports to submit quarterly reports to the FDA about malfunctions for those devices. Since the FDA has not yet identified which of these devices require reporting to the FDA, the FDA is clarifying that its failure to identify this class of devices does NOT impact the continuing obligation of importers to report malfunctions to manufacturers.