Section 513 of the Federal Food, Drug, and Cosmetic Act requires FDA to consider the least burdensome means of evaluating device safety and effectiveness for Class III devices and substantial equivalence for devices requiring 510(k) clearance. Despite this legal requirement, the device industry’s position has been that FDA does not comply with the provisions to require only the “least burdensome” means of establishing device effectiveness or substantial equivalence. It has often seemed that CDRH was paying lip service to the concept of “least burdensome,” using the phrase but not actually applying it. The 21st Century Cures Act (Cures), signed into law last December, added language requiring CDRH to assess the implementation of the least burdensome provisions “to ensure that the least burdensome requirements are fully and consistently applied.”
As part of this implementation, on December 15, CDRH issued a revised draft guidance regarding the Least Burdensome provisions. Once finalized, this guidance will replace FDA’s October 2002 guidance, “The Least Burdensome Provisions of the FDA Modernization Act of 1997: Concept and Principles.”
The draft guidance applies a new definition of “least burdensome,” defining it as “the minimum amount of information necessary to adequately address a regulatory question or issue through the most efficient manner at the right time.” In contrast, the 2002 guidance defined least burdensome as “a successful means of addressing a premarket issue that involves the most appropriate investment of time, effort, and resources on the part of industry and FDA.” The earlier definition focused on premarket issues, whereas the new guidance is broader. The scope of the draft guidance includes all premarket submissions, including de novos and Q-submissions, neither of which were expressly included in the 2002 guidance. Both guidances also cover other regulatory obligations, including, for example postmarket surveillance and post-approval studies.
Although Cures was directed at CDRH, the Center has turned around and applied the concepts to industry. The draft guidance emphasizes that least burdensome applies not only to FDA but also to industry. The guidance states that industry should “submit well-organized, clear, and concise information” that is least burdensome to review. In practice, it is difficult for industry to predict the minimum amount of information necessary in a premarket submission because the Agency continues to request new and different information to establish a reasonable assurance of safety and effectiveness or substantial equivalence.
The new guidance, like the 2002 guidance, provides a number of examples of how FDA has and will apply its least burdensome provisions. The draft guidance utilizes more recent examples of the least burdensome provisions as compared to the 2002 guidance. For example, the guidance references use of real world evidence, a current hot topic within the Agency. With these more recent examples, however, some of the more basic examples from the 2002 guidance have been lost. For example, the 2002 guidance clearly indicated that 510(k) submissions do not need to include manufacturing information. This same information is not in the 2017 draft. This document will supersede what FDA said before. We recommend that FDA include the examples from the 2002 guidance to the extent that they reflect current policy. In general, we find the new examples to be helpful; however, omitting examples that have been useful in the past will mean a loss of useful illustrations and could potentially create confusion as to whether leaving out the examples means CDRH has changed its policy.