# Design Considerations for Pivotal Clinical Investigations for Medical Devices:  Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/design-considerations-for-pivotal-clinical-investigations-for-medical-devices-guidance-for-industry-clinical-investigators-institutional-review-boards-and-fda-staff/70ecd475-412f-4924-ace8-87075c777f34

> FDA guidance document: Design Considerations for Pivotal Clinical Investigations for Medical Devices:  Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA Staff. Issue date: November 07, 2013. Get complete insights and analysis.

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## Details

- Title: Design Considerations for Pivotal Clinical Investigations for Medical Devices:  Guidance for Industry, Clinical Investigators, Institutional Review Boards and FDA 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: 2013-11-07
- Last Changed: 2023-08-10
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0567">FDA-2011-D-0567</a>

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