# Design Control Guidance For Medical Device Manufacturers:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/design-control-guidance-for-medical-device-manufacturers-guidance-for-industry/a58d3f96-e74a-4ff7-a00a-ba7e9c9306a3

> FDA guidance document: Design Control Guidance For Medical Device Manufacturers:  Guidance for Industry. Issue date: March 11, 1997. Get complete insights and analysis.

---

## Details

- Title: Design Control Guidance For Medical Device Manufacturers:  Guidance for Industry
- 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: 1997-03-11
- Last Changed: 2020-03-18
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2020-D-0957">FDA-2020-D-0957</a>

## Related Documents

- [Guidance on Premarket Notification 510(k) for Sterilizers Intended for Use in Health Care Facilities](https://www.globalkeysolutions.net/guidances/guidance-document/guidance-on-premarket-notification-510k-for-sterilizers-intended-for-use-in-health-care-facilities/2af1cad4-e00e-4637-a61b-4259a1c50bd4)
- [Software as a Medical Device (SAMD): Clinical Evaluation:  Guidance for Industry and Food and Drug Administration Staff](https://www.globalkeysolutions.net/guidances/guidance-document/software-as-a-medical-device-samd-clinical-evaluation-guidance-for-industry-and-food-and-drug-administration-staff/745234d9-1b52-4aa1-aff4-297a93f801f8)
- [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)