Given the fact that the FDA probably doesn’t know what it plans to do in 2014, predicting their actions is challenging, to put it mildly.

With that slightly weasel-like caveat, it’s worth noting three events in 2013 that will almost certainly impact 2014.

CDRH’s Office of Compliance reorganization

With the addition of a Division of International Compliance Operations, watch for the FDA to shift focus and some budget funds to increased inspection and audits of foreign device manufacturers, and increased crackdowns on promotional claims (see below). Steve Silverman, the director of the Office of Compliance, is making the public relations rounds with events at trade shows and the like. He’s stressing that the Office of Compliance’s new “look” will better harmonize and broaden enforcement efforts. We’ll keep an eye on this and report back.

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