A Wolf in Sheep’s Clothing: When the Failure to Obtain a 510(k) for a Modification Is More Than a Regulatory Violation

September 7, 2016By: Jeffrey N. Gibbs & Anne K. Walsh Download PDF

The recent issuance of FDA’s draft guidance, Deciding When to Submit a 510(k) for a Change to an Existing Device, which, when finalized, will replace the guidance of the same name issued in January 1997, was undoubtedly met with both excitement and trepidation for companies with products marketed under a 510(k) clearance. Trepidation because in 2011, FDA issued a controversial draft guidance on this issue that would have significantly increased the circumstances under which a 510(k) would need to be submitted for a modification. And excitement because not only is an update to the 1997 guidance well overdue, but also because in 2012 Congress held FDA accountable for the positions it took in the 2011 draft, required FDA to withdraw that draft and operate under the 1997 guidance, and mandated that FDA provide to Congress a report describing when a new 510(k) is needed for a modification to a cleared device.

The impact of the draft guidance may be even more significant: the failure to obtain a new 510(k) for a modification could expose a company to civil and criminal charges brought by the Department of Justice. As evidenced in recent cases, to avoid the First Amendment “issue,” the government is taking a new tack: charging medical device companies engaged in off-label promotion with a failure to have a new 510(k), and criminalizing what has traditionally been considered a regulatory violation. The difference is subtle but important because it shifts the allegation from speech, which may be protected by the First Amendment, to conduct, which relates to the company’s failure to have a new 510(k).

This article describes recent cases brought against medical device companies for a failure to obtain a new 510(k) and the disparate results from them.