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  1. IND & IDE Support

Investigational Device Exemption (IDE) Templates

Formatting and Submission Requirements (Tip Sheet)

Initial IDE Application Templates

  1. Cover Letter for Original IDE Application
  2. Initial IDE Application (body of application)
  3. Report of Prior Investigation(s) of the Device (required section of the application)
  4. Investigational Plan - Feasibility Study (required section of the application if a feasibility study will be conducted)
  5. Investigational Plan - Pivotal Study (required section of the application if a pivotal study will be conducted)
  6. Methods, Facilities, and Control Information (required section of the application)
  7. Example Investigator's Agreement (required section of the application)

Required Reports

  1. Progress Report
  2. Safety Report
  3. Final Report

Supplements

  1. Cover Letter for Supplemental IDE Application
  2. Cover Letter for 5-Day Notification

Requests

  1. Request for feedback or meeting (Q submission)
  2. IDE Exemption Request

Form Template

Certification/Disclosure of Financial Interest of Clinical Investigators

IND & IDE Support

  • Do I Need an IND?
  • Do I Need an IDE?
  • FDA Forms
  • IND Templates
  • IDE Templates
  • Expanded Access (Drugs)
  • Compassionate Use (Devices)

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Education & Compliance Support for Human Subject Research
Office of Research Protections
Heiber Building, Suite 205
3500 Fifth Avenue,
Pittsburgh, PA 15213
FAX: 412-383-1388

 

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Revised 01/19/21Copyright 2021