On August 8, 2016, the FDA issued draft guidance on “Deciding When to Submit a 510(k) for a Change to an Existing Device.” Current regulations provide that a manufacturer of a medical device must submit a premarket notification submission to the FDA at least 90 days before beginning to sell a device that has been changed or modified in any manner “that could significantly affect the safety or effectiveness of the device.” 21 C.F.R. § 807.81(a)(3). The draft guidance clarifies this language, providing more specific examples of when a 510(k) submission must be made.
The draft guidance, although it is not final nor binding, is significant not only because it should assist medical device manufacturers in determining when a 510(k) submission should be made. The increased clarity also bolsters the likelihood of a medical device manufacturer being able to successfully employ an implied preemption argument akin to those that have been successfully used with respect to generic drugs (see PLIVA v. Mensing, 564 U.S. 604 (2011) and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013)) to defeat state law tort claims. In the generic drug context, a generic drug manufacturer cannot unilaterally change its label because it has the duty of sameness with respect to the brand drug. Accordingly, courts have concluded that state law claims against such manufacturers – typically alleging that the generic drug manufacturer was somehow negligent by failing to immediately provide a specific warning on its label – are impliedly preempted because the generic drug manufacturer could not immediately alter its label on its own without violating the law. As the Court said in Mensing, “[i]f the Manufacturers had independently changed their labels to satisfy their state-law duty, they would have violated federal law…Thus, it was impossible for the Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.”
To date, attempts by medical device manufacturers to make an analogous argument, i.e. that they could not immediately change their device to make it safer (thus complying with a duty pursuant to state tort law) because such a change would require submitting a new 510(k) to the FDA and waiting 90 days (thus complying with an obligation under federal law), have been unsuccessful. By clarifying instances in which a 510(k) must be submitted, the draft guidance increases the possibility of medical device manufacturers successfully defending against state tort claims on this basis.