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# Developing, Responding to Device Deficiencies Guidance
- URL: https://www.fdaweb.com/developing-responding-to-device-deficiencies-guidance/
- Published: 2022-10-26T12:00:00.000Z
- Updated: 2026-09-14T18:04:22.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153057

FDA has published a guidance, *Developing and Responding to Deficiencies in Accordance with the Least Burdensome Provisions*, to help agency staff develop a request for additional information needed to decide on a medical device marketing application under the “least burdensome” provisions of the Federal Food, Drug, and Cosmetic Act. FDA says the [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/developing-and-responding-deficiencies-accordance-least-burdensome-provisions?ref=fdaweb.com) also describes suggested formats for staff to communicate deficiencies, and for industry to use for responses to such requests.

“This guidance includes examples of well-constructed deficiencies and industry responses to facilitate an efficient review process,” the document says. “This guidance also details supervisory review, major/minor deficiencies, additional considerations, and prioritization of deficiencies in FDA deficiency letters.”