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# Least Burdensome Guidance Outlined
- URL: https://www.fdaweb.com/least-burdensome-guidance-outlined/
- Published: 2019-03-26T12:00:00.000Z
- Updated: 2026-09-15T01:15:51.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143700

A 3/14 CDRH Webinar discussed the 2/5 final guidance on concepts and principles of the “least burdensome” regulatory information provisions. CDRH Office of Device Evaluation regulatory advisor **Joshua Silverstein** [said](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm630365.htm?ref=fdaweb.com) the guidance describes the agency’s use of the least burdensome approach through medical device regulation to remove or reduce unnecessary burdens that could delay marketing of beneficial products while maintaining the legal requirements for clearance and approval.

He reported that 79 comments were received on the draft guidance from 13 external stakeholders. Most of the comments supported the proposal, he said, and there were revisions and additional requests on the least burdensome definition and guiding principles.

The seven least burdensome guiding principles identified by Silverstein from the guidance are: 

- FDA intends to request the minimum information necessary to adequately address the regulatory question or issue at hand;
- industry should submit material including pre-market submissions to FDA that are least burdensome for FDA to review;
- FDA intends to use the most efficient means to resolve regulatory questions and issues;
- the right information should be provided at the right time;
- regulatory approaches should be designed to fit the technology, considering its unique innovation cycles, evidence generation needs, and timely patient access;
- 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
- FDA intends to apply least burdensome principles in international medical device convergence and harmonization efforts.