FDA’s Final Guidance Pushes Companies to be Recall Ready

By MedTech Intelligence Staff

The agency is urging manufacturers to not only have recall policies in place before a recall is necessary, but to also act quickly in initiating a recall when public health is at risk.

In an effort to help companies be more recall ready, the FDA has finalized a guidance document that reviews how companies should have proper product coding and keep distribution records to facilitate faster and more accurate recall actions. The guidance, Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C, describes the steps that companies should take before a recall is necessary; and training, planning and record-keeping procedures that can limit public exposure to risk by reducing the amount of time a recalled product is on the market. The guidance applies to voluntary recalls of products under FDA’s jurisdiction.

The document provides guidance on the following:

  • How a firm in a product distribution chain should prepare to facilitate timely initiation of a voluntary recall
  • Recommended procedures for initiating a recall and performing actions related to initiating a recall
  • What a firm should do if there is an indication of a problem with a distributed product
  • How a firm should initiate a voluntary recall
  • How FDA works with a recalling firm to initiate a voluntary recall in a timely manner

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