FDA Explains How to Do Less to Get More: Least Burdensome Approach
[Thursday, February 7, 2019]
FDA released its promised guidance on the least burdensome approach for medical devices this week which details the various options available to device developers for taking alternative approaches to regulatory submissions. FDA defined the least burdensome approach as “the minimum amount of information necessary to adequately address a relevant regulatory question or issue through the most efficient manner at the right time”. The guidance goes into great details on how manufacturers can reduce the amount of information included in their applications to FDA and when responding to FDA’s request for comments with specific examples. The least burdensome approach is not new; the first guidance on least burdensome was release in the year 2000. However, over time, despite the intent of the regulators to reduce the amount of information needed to support market approval of devices, the amount of information actually submitted by the developers in applications has increased. So much so, that in the 21st Century’s Cure Act of 2016, the Congress added specific mandates for FDA to make specific recommendations for reducing information needed. And for the last two years, FDA has been making steady progress to implement the culture of least burdensome review in the Center for Devices. Exactly one year ago, FDA announced specific measures to encourage least burdensome approach. The guidance this week further extends those steps. FDA intends to request minimum information in support of applications, industry to submit clear, concise and relevant information to FDA, and FDA would accept all kinds of alternate data from manufactures. Alternative sources of data may include peer-reviewed literature, registry data, outside the U.S. (OUS) data, real-world evidence (RWE), and well-documented case histories. Non-clinical data such as bench-top testing, computer modeling and simulations can be used instead of or to supplement clinical data. Sponsors should try to reduce traditional clinical trials by using historical controls, cross-over study design, and adaptive trials. The guidance provides various tips for using alternate data sources and strategies to reduce the burden of regulatory applications. In general, FDA expects sponsors to provide the least information needed to support regulatory decisions, provide timely documents, meet FDA to discuss alternate pathways to generate supporting data, and in general, reduce the quantity of data and rather focus on precise and relevant data for successful outcome. The least burdensome guidance has been there for many years, but it seems there has been a disconnect between FDA’s intent and industry’s interpretation of the regulatory requirements. While the least burdensome approach does not change the regulation, it provides several options to chose from to meet regulatory requirements while minimizing data. The new guidance should be a must read for all developers of medical devices.