# Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology:  Guidance for Industry and Food and Drug Administration Staff – FDA Guidance

Source: https://www.keypedia.com/guidances/guidance-document/technical-considerations-for-medical-devices-with-physiologic-closed-loop-control-technology-guidance-for-industry-and-food-and-drug-administration-staff/5b98dd0f-3b60-4ea7-b3c6-d7e17e5b540c

> FDA guidance document: Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology:  Guidance for Industry and Food and Drug Administration Staff. Issue date: September 29, 2023. Get complete insights and analysis.

---

## Details

- Title: Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology:  Guidance for Industry and Food and Drug Administration Staff
- Communication Type: Guidance Document
- Product Type: devices
- Office Name: Center for Devices and Radiological Health
- Office URL: /offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7
- Issue Date: 2023-09-29
- Comment Close Date: 2022-02-22
- Last Changed: 2023-10-06
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-0996">FDA-2021-D-0996</a>

## Related Documents

- [Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices:   Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/use-of-real-world-evidence-to-support-regulatory-decision-making-for-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/d18b3a42-ad8b-4987-8955-ea08f4372049)
- [Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents:  Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/referencing-the-definition-of-device-in-the-federal-food-drug-and-cosmetic-act-in-guidance-regulatory-documents-communications-and-other-public-documents-guidance-for-industry-and-food-and-drug-administration-staff/d129e237-573b-4154-b731-0db0644370be)
- [Content of Premarket Submissions for Device Software Functions:  Guidance for Industry and Food and Drug Administration Staff](https://www.keypedia.com/guidances/guidance-document/content-of-premarket-submissions-for-device-software-functions-guidance-for-industry-and-food-and-drug-administration-staff/0cee2fd2-94a6-466f-b1b8-836fd3c8d30f)