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# Guidance on Deficiencies in Device Submissions
- URL: https://www.fdaweb.com/guidance-on-deficiencies-in-device-submissions/
- Published: 2017-09-29T12:00:00.000Z
- Updated: 2026-09-14T22:53:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139745

FDA has made available a guidance on “Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions.” The document is intended to help FDA staff develop a request for additional information (deficiency in the submission) needed to make a decision on a medical device marketing application in accordance with the least burdensome provisions of the Food, Drug, and Cosmetic Act. It describes suggested formats for FDA staff to communicate deficiencies, and for industry to use for responses to such requests, in order to make efficient use of industry and FDA’s time. The guidance includes examples of well-constructed deficiencies and industry responses to facilitate an efficient review process. To view the guidance, click [here](https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM073680.pdf?ref=fdaweb.com).