Are FDA Guidance Documents Nonbinding?

The FDA used to be able to send its lawyers from the Department of Justice (DOJ) to threaten medical device manufacturers (among others) with civil penalties if the agency’s guidance documents weren’t being followed.

But now the lawyers at DOJ are saying, not so fast, guidance documents are not binding documents and can’t take the place of formal regulatory rulemaking required under the Administrative Procedure Act.

According to the FDA Law Blog, Deputy Associate Attorney General Stephen Cox spoke at the Federal Bar Association Qui Tam Conference on February 28, 2018. Cox described federal agencies’ use of guidance in lieu of formal regulatory rulemaking required under the Administrative Procedure Act: “Rulemaking can be cumbersome and slow, of course, and sometimes agencies have used guidance as a short-cut to effectively make new rules when they should have undertaken notice-and-comment rulemaking instead.”

In short, device makers have every right to take a different “lawful approach.”

Cox, states the blog, “referenced a recommendation from the Administrative Conference of the United States (ACUS) to make clear that ‘the public may take a lawful approach different from the one set forth in’ a guidance document.” Cox said a recent DOJ memo implements the ACUS recommendation.

“Nonbinding” Guidance Document

“The [memo] makes clear that we won’t be using noncompliance with a guidance document to prove a violation of the applicable statute or regulation. In other words, we won’t use our affirmative civil enforcement authority to effectively convert a nonbinding guidance document into a requirement that has the force or effect of law.”

510(k) Impact

Anne Walsh, an attorney with Hyman, Phelps & McNamara, publisher of the blog, provides an example of how this new legal interpretation of guidance documents might impact a company’s decision of how to seek 510(k) clearances from the agency.

Walsh writes, “FDA regulation requires the submission of a new 510(k) under certain circumstances, and FDA guidance walks through the analysis FDA recommends determining whether a new 510(k) is required.”

“Many companies prepare a Letter to File to evidence its decision not to file a new 510(k), but this is not a requirement by statute or regulation. Per DOJ policy, ‘if there’s a guidance document that expands upon that regulatory requirement—by suggesting that there are additional requirements or prohibitions that go beyond what the regulation actually says—then we’re not going to use noncompliance with those supposed ‘requirements’ to show that a party violated the regulation.’”

“Thus, a company’s failure to document its decision-making cannot be used to solely support a civil enforcement action against a company for failing to submit a new 510(k).”

“Arbitrary and Unpredictable” Enforcement Action

Ethan Davis, the soon-to-be former Deputy Assistant Attorney General for the Consumer Protection Branch (CPB), is leaving DOJ to clerk for Supreme Court Justice Neil Gorsuch. In a recent speech, according to the blog, Davis described the basic tenet that “[i]n our system, law is made by statute, and regulations are made by notice and comment rulemaking. Neither should be made by guidance documents.” And Davis renewed the commitment by DOJ CPB to “create an enforcement environment premised on the rule of law, so that you as regulated entities do not feel subjected to arbitrary and unpredictable enforcement actions.”

Walsh concludes that only time will tell whether these DOJ principles are followed in future enforcement actions, “but it behooves companies to remind DOJ of these stated principles if prosecution appears not grounded in law and only in guidance.”