Are Mock Recalls Required by the FDA?

Conducting a mock recall is not a formal regulatory requirement of the FDA. The FDA recently released its FDA guidance that stresses the importance of being “recall ready” and outlines steps companies should take to develop recall policies and procedures that includes recall planning, training, and record-keeping across all departments to reduce the time a recalled product stays on the market. This effects medical device, consumer products, food, drug industries and others.

To help create and test recall plans, mock recalls can prepare companies for an actual event. In some cases a recall could involve 100+ individuals, within an organization, trying to coordinate all recall efforts. From QA to sales, legal to PR, purchasing to production, operation to marketing, and many more are involved in a mock recall exercise. With this in mind, it is common for medical device, food, drug, consumer product companies to test their recall plan once or twice a year. Why? Because many individuals, within an effected department change, and the new players need training in the mock recall exercises to test their recall readiness.

Guidance documents represent FDA’s current thinking on a topic. They do not create or confer any rights for or on any person and do not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.

The FDA offers a list of industry guidelines as it relates to market recalls and withdrawals.