> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments on Physiologic Closed-Loop Guidance
- URL: https://www.fdaweb.com/comments-on-physiologic-closed-loop-guidance/
- Published: 2022-02-23T12:00:00.000Z
- Updated: 2026-09-14T17:33:45.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5151222

Medtronic says it appreciates FDA efforts to establish appropriate considerations for premarket submissions for medical devices with physiologic closed-loop control technology. Commenting on the agency’s 12/23/21 draft guidance on the topic, the company [says](https://www.regulations.gov/comment/FDA-2021-D-0996-0014?ref=fdaweb.com) it also appreciates the agency’s recognition of the value of computational models as an alternative or to supplement bench, animal, and/or clinical studies.

The company further says it appreciates that the draft uses already developed standards and says the relevant requirements applicable to physiologic closed-loop controlled devices should be aligned as closely as possible with IEC 60601-1-10\. “Medtronic is concerned that deviation from the IEC standard will add unnecessary burden beyond what is required by IEC 60601-1-10 and cause inconsistency with the standard without improving patient safety or device effectiveness,” the comment says.

The BD comment [letter](https://www.regulations.gov/comment/FDA-2021-D-0996-0011?ref=fdaweb.com) gives specific line-by-line comments, including a statement that while the draft provides a good initial list of devices that are applicable, it could be improved with additional examples that also are relevant to the proposal.

Line-by-line technical [comments](https://www.regulations.gov/comment/FDA-2021-D-0996-0012?ref=fdaweb.com) also came from Tandem Diabetes Care.