Conducting Global Clinical Research Trials:

Comparing and Contrasting FDA Medical Device Regulations for Clinical Investigations with ISO 14155:2011

Today’s clinical research landscape for the medical device industry is global in nature. Whether conducting a U.S. study with additional international sites, or conducting the entire study outside the US, sponsors must be well-informed about the multiple requirements in order to run a well-controlled trial that will withstand the scrutiny of worldwide regulatory agencies. Conducting a trial under the umbrella of both 21 CFR and ISO 14155:2011 (ISO 14155) will position the sponsor well globally at trial end, but implementing this can create confusion and chaos during study conduct.

With a focus specifically on clinical investigators, this white paper will examine common findings from FDA inspections done both in the US and internationally, and highlight some differences between 21 CFR and ISO 14155 related to those findings that would be beneficial for study teams to know.