FDA clarifies surveillance orders for device manufacturers

In 2006, the Federal Food, Drug and Cosmetic Act gave the FDA the power to require manufacturers to conduct postmarket surveillance for certain type of devices. Now, a decade later, the FDA has released guidance for these manufacturers.

The guidance is intended to assist manufacturers of devices subject to section 522 postmarket surveillance orders imposed by the FDA by providing:

  • an overview of section 522 of the act;
  • information on how to fulfill section 522 obligations; and
  • recommendations on the format, content, and review of postmarket surveillance plan submissions.

The FDA is able to order section 522 postmarket surveillance orders when a device is approved for use or approval any time thereafter. The company must follow such an order within 15 months of issuance.

Such surveillance orders may be orders for situations, either pre- or postmarket, in order to:

  • better understand the nature, severity, or frequency of suspected problems reported in adverse event reports or in the published literature;
  • obtain more information on device performance associated with real-world clinical practice;
  • address long term or infrequent safety and effectiveness issues for implantable and other devices for which the premarket testing provided more limited information. For example, premarket evaluation of a device may have been based on surrogate markers. Once the device is actually marketed, postmarket surveillance may be appropriate to assess the effectiveness of the device in detecting or treating the disease or condition, rather than the surrogate; and
  • to better define the association between problems and devices when unexpected or unexplained serious adverse events occur after a device is marketed, if there is a change in the nature of serious adverse events, or if there is an increase in the frequency of serious adverse events.

Manufacturers must submit surveillance plan proposals to the FDA for approval, which the agency says ensures the necessary information will be collected to answer surveillance or safety questions.