The United States Food and Drug Administration (FDA) recently issued Draft Guidance for Industry entitled “Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C” (the Draft Guidance). 1/ As FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier explained, part of FDA’s work is “keenly focused on guiding companies on steps needed to ready their facilities and staff for possible recall situations.” The Draft Guidance is the latest step in the Agency’s efforts over the past 18 months to proactively and systematically update the FDA recall process.

Plaiser points to several examples of recalls that took place in the past 12 months that demonstrate that the improvements FDA and industry have implemented can result in more timely information being available to consumers. Plaisier also states that the agency’s work to improve recall timeliness will continue and that FDA encourages the use of new technologies that can identify and communicate recall events more quickly and efficiently.

The Draft Guidance has four sections: A) preparing to facilitate timely initiation of a voluntary recall, B) identifying and responding to potential problems with distributed product, C) initiating a voluntary recall, and D) FDA’s role in initiating a voluntary recall in a timely manner. In terms of significance, Plaisier highlights three key recommendations – training, record keeping, and procedures.

This post is a summary of the FDA draft guidance document. Click here to read more.