# Remanufacturing of Medical Devices:  Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/remanufacturing-of-medical-devices-guidance-for-industry-entities-that-perform-servicing-or-remanufacturing-and-food-and-drug-administration-staff/64f116aa-ebd5-47c9-9941-2a120cd08231

> FDA guidance document: Remanufacturing of Medical Devices:  Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff. Issue date: May 10, 2024. Get complete insights and analysis.

---

## Details

- Title: Remanufacturing of Medical Devices:  Guidance for Industry, Entities That Perform Servicing or Remanufacturing, 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: 2024-05-10
- Last Changed: 2024-05-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-N-3741">FDA-2018-N-3741</a>

## Related Documents

- [Electronic Submission Template for Medical Device De Novo Requests:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/electronic-submission-template-for-medical-device-de-novo-requests-guidance-for-industry-and-food-and-drug-administration-staff/8bd49234-647d-4582-b2b5-adc2a5d75f1c)
- [Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/medical-device-data-systems-medical-image-storage-devices-and-medical-image-communications-devices-guidance-for-industry-and-food-and-drug-administration-staff/12c2c43f-83da-46b3-84e4-d3b7216e904f)
- [Safer Technologies Program for Medical Devices:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/safer-technologies-program-for-medical-devices-guidance-for-industry-and-food-and-drug-administration-staff/550343a5-c0c9-44e5-9b3e-333f80238188)