# Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling :  Guidance for Industry and Food and Drug Administration Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/reprocessing-medical-devices-in-health-care-settings-validation-methods-and-labeling-guidance-for-industry-and-food-and-drug-administration-staff/ff9bb589-ce45-48ed-a673-3d3302436dc0

> FDA guidance document: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling :  Guidance for Industry and Food and Drug Administration Staff. Issue date: March 17, 2015. Get complete insights and analysis.

---

## Details

- Title: Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling :  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: 2015-03-17
- Last Changed: 2020-03-02
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0293">FDA-2011-D-0293</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.globalkeysolutions.net/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)
- [Annual Reports for Approved Premarket Approval Applications (PMA) :  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/annual-reports-for-approved-premarket-approval-applications-pma-guidance-for-industry-and-food-and-drug-administration-staff/571b5649-d42a-4ea5-96f0-88bc553832be)
- [Content of Premarket Submissions for Device Software Functions:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/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)