# Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/labeling-regulatory-requirements-for-medical-devices-fda-89-4203/2529e098-29ec-403e-8ab0-0b4f285bdd9e

> FDA guidance document: Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203). Issue date: September 01, 1989. Get complete insights and analysis.

---

## Details

- Title: Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203)
- 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: 1989-09-01
- Last Changed: 2020-03-17
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

## Related Documents

- [Shelf Life of Medical Devices](https://www.globalkeysolutions.net/guidances/guidance-document/shelf-life-of-medical-devices/1f8de165-791b-40a8-80ef-bb23aaa44467)
- [Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 )](https://www.globalkeysolutions.net/guidances/guidance-document/clarification-of-radiation-control-regulations-for-diagnostic-x-ray-equipment-part-1/47feea8e-50d2-4ced-8d6b-c113395f92f8)
- [Guidance on Premarket Notification [510(k)] Submissions for Surgical Gowns and Surgical Drapes](https://www.globalkeysolutions.net/guidances/guidance-document/guidance-on-premarket-notification-510k-submissions-for-surgical-gowns-and-surgical-drapes/118e833d-a32a-4db6-ac38-5ca74f146e5d)