Earlier this week, a popular source of regulatory news published an article claiming FDA “finalized a new rule this week that prohibits manufacturers from using so-called “split-predicates”. However, it appears that the article may instead be referencing the Final Guidance for Industry and Food and Drug Administration Staff entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]” that FDA published earlier this week. Unfortunately, as often occurs on the Internet, the post was disseminated by several other popular sources of regulatory news.
This confusion comes a little less than three months after four Senator’s sent a letter to FDA raising concerns about FDA draft guidance “becoming the default FDA policy and position.”
Guidances and final rules carry different legal weight. Final regulations are legislative rules that have the force of law. Whereas, guidances do not set new legal standards, impose legal requirements or have the force of law. Instead guidances are issued to help interpret or clarify an existing regulation.
FDA certainly understands this difference. As FDA notes, “FDA regulations are  federal laws, [even though] they are not part of the [federal Food Drug & Cosmetic Act (FD&C Act)].” Whereas, “FDA guidance describes the agency’s current thinking on a regulatory issue [but guidance] is not legally binding on the public or FDA.”
FDA also emphasizes this latter point in many of its guidance documents by including the following disclaimer:
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
Unfortunately, not everyone fully appreciates the difference between rules and guidance. The recent confusion suggests that there is a disconnect between FDA’s position on the difference between guidance and final rules and the understanding of at least some in industry. Therefore, as FDA reviews its current guidance development practice, it is important that FDA look for ways to ensure (draft or final) guidance is just that, guidance. For example,
- FDA should make the guidance development process more efficient and so that there is a significant difference between the time it takes to publish a final guidance and the time it takes to implement a final rule;
- If a manufacturer uses an alternative approach and provides reasonable support for taking such an approach, FDA should be required to provide a reasonably explanation as to why the alternative is insufficient;
- FDA should include a process for quickly and efficiently incorporating alternative approaches into existing final guidance.