Aug 28, 2019

A recent survey conducted by the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) has revealed several areas in need of improvement, according to the agency.

The CDRH survey, the results of which were published in Contemporary Clinical Trials (subscription required), assessed 399 informed consent forms (ICFs) used in Investigational Device Exemption (IDE) applications submitted to the FDA division in 2015 and 2016.

Evaluating the ICFs for readability and structure, CDRH investigators reported a lack of consistency in terms of form length, lack of clarity in terms of short sentences, and the need for greater use of visual aids such as tables, graphs and diagrams.

“The intent of the article is to demonstrate that improvements are needed in the (informed consent) process and to encourage clinical trial stakeholders to consider implementing those approaches that optimize patient comprehension in the development of their IC process,” write the CDRH survey authors in their abstract.

Eventually, these survey findings may be used to support more formal CDRH recommendations to change ICF structure and readability in IDE applications.

Related FDA IDE and clinical study resources from Emergo by UL:

  • Clinical research support for medical device companies
  • US FDA Pre-Sub (Q-Sub) consulting for medical device manufacturers
  • Whitepaper: Clinical data to support FDA 510(k) submissions



  • Stewart Eisenhart