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# FDA Updates ‘Least Burdensome’ Guidance
- URL: https://www.fdaweb.com/fda-updates-least-burdensome-guidance/
- Published: 2017-10-12T12:00:00.000Z
- Updated: 2026-09-14T22:55:47.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139857

FDA has updated its guidance on developing and responding to deficiencies in accordance with the least burdensome provisions that was first issued 17 years ago. Attorney **Adrienne Lenz** (Hyman, Phelps & McNamara) says in an online [post](http://www.fdalawblog.net/fda%5Flaw%5Fblog%5Fhyman%5Fphelps/2017/10/fda-updates-least-burdensome-guidance-after-17-years.html?ref=fdaweb.com) in her firm’s *FDA Law Blog* that the revised guidance sets forth principles for the agency in writing deficiency letters and provides a suggested format for industry responses to FDA deficiencies. Sponsors can use the principles when explaining to FDA why they consider that a particular request for additional information is not “least burdensome,” she says.

New to the guidance, Lenz says, are these six principles: 

- information unrelated to the regulatory decision should not be part of the decision-making process;
- alternative approaches to resolving regulatory issues should be considered to optimize the necessary time, effort, and resources involved in developing a response;
- deficiency letters should request the least burdensome amount of information necessary to adequately address the identified issue in the most efficient manner at the right time;
- major deficiencies are those based on least burdensome principles that, if not resolved, will preclude a favorable decision on the marketing application;
- if the agency includes minor deficiencies identified during the review in the deficiency letter, it should identify those requests separately from major issues and whenever possible try to resolve minor questions/issues interactively; and
- FDA may also include additional considerations that are suggestions, recommendations, or requests that are not expected to preclude a favorable decision on the marketing application.

Another new requirement from the MDUFA 4 reauthorization commitment letter is that all deficiency letters are to undergo supervisory review before they are issued, Lenz writes.

“All in all,” she concludes, “while the ‘least burdensome’ requirement has never had a lot of teeth in it, we are hopeful that the new guiding principles, specific references, and supervisory review will help keep FDA’s deficiency letters focused on the minimum information necessary to reach a regulatory decision.”