Draft guidance documents have been proposed and are issued for public comment. Each FDA draft document lists how to submit comments to the agency.
The entries below are listed in reverse chronological order by publication date.
Draft Guidance Documents
- Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States (PDF - 649KB) -04/2015
Investigational New Drug Applications (INDs)-Determining Whether Human Research Studies Can Be Conducted Without an IND(PDF - 288KB) -09/2013
Use of Electronic Informed Consent in Clinical Investigations – Questions and Answers(PDF - 110KB) -03/2015
Informed Consent Information Sheet-07/2014
- Humanitarian Device Exemption (HDE): Questions and Answers -03/2014
Charging for Investigational Drugs Under an IND — Qs & As(PDF - 57KB) -05/2013
Expanded Access to Investigational Drugs for Treatment Use — Qs & As(PDF - 75KB) -05/2013
Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products(PDF - 997KB) -12/2012
Electronic Source Data in Clinical Investigations(PDF - 190KB) -09/2013
- Exculpatory Language in Informed Consent (PDF - 112KB) -08/2011
Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring(PDF - 109KB) -08/2013
- Factors to Consider when Making Benefit-Risk Determinations in Medical Device Premarket Review -08/2011
- Commercially Distributed In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions -11/2013