CDRH hosted a webinar on March 14th to review the current state of the Least Burdensome approach following issuance of an updated final guidance on February 5, 2019. The purpose of the approach is the remove or reduce unnecessary burden during the regulatory process while still meeting the statutory requirements for clearance and approval. The webinar presents a summary of the guidance along with additional details on the history of the Least Burdensome approach and the comments on the latest draft guidance. 

The approach applies to all medical products designated as devices (including the device part of combination devices). There are 7 basic principles under the updated guidance:

1. The FDA intends to request the minimum information necessary to adequately address the regulatory question or issue at hand;
2. Industry should submit material including pre-market submissions to the FDA that are Least Burdensome for FDA to review;
3. FDA intends to use the most efficient means to resolve regulatory questions and issues (using both formal and informal/interactive approaches whenever possible);
4. The right information should be provided at the right time, for example, just in time data collection, to address the right questions;
5. Regulatory approaches should be designed to fit the technology taking into account its innovation cycles, evidence generation needs, and timely patient access.
6. The FDA intends to leverage data from other countries and decisions by or on behalf of other national medical device regulatory authorities to the extent appropriate and feasible; and
7. The FDA intends to apply Least Burdensome principles in international medical device convergence and harmonization efforts.

The first 5 principles confirm the approach applies to both FDA requests and device submissions. The last 2 principles apply to the agency’s use of device regulatory information from other countries and interaction with international harmonization efforts for devices.

The webinar closes with a review of the Least Burdensome implementation efforts conducted so far. A key point is the renewal of the Least Burdensome Pilot program for 510(k) submissions, since the feedback from the original program (conducted in 2018 and reviewed during the webinar) showed use of a Least Burdensome flag was simpler than an appeal process and would provide a useful performance metric for the approach. The recorded presentation (along with printable slides and transcript) is available at the webinar page; the final guidance is available here.

Text Copyright © 2019 Katrina Rogers