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Compliance In Focus
Posted by John Lehmann on Thu, Aug 21, 2014

Understanding the Difference Between FDA Regulations and ISO 14155

Understanding the Difference Between FDA Regulations and ISO 14155As industry begins conducting more and more device trials globally, now more than ever it is crucial to understand the important differences that exist between the FDA’s regulations and the international standards of ISO 14155.  IMARC Research has created a new whitepaper that highlights these differences.

Whether conducting a US-based study with additional international sites or conducting an entire study outside the US, sponsors must stay well-informed about the multiple national and international requirements set to ensure a well-controlled trial that will withstand the scrutiny of worldwide regulatory agencies.  While 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, implementing these dual standards 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, as well as highlighting  key differences between 21 CFR and ISO 14155 related to those findings that could be beneficial for study teams to know.

Just as the FDA seeks to protect public health and human subject well-being through cautious oversight of all US clinical device trials, ISO 14155 was created to clarify worldwide the design, conduct, recording, and reporting of clinical investigations carried out in human subjects that assess the safety or performance of medical devices for regulatory purposes. 

Conducting an investigation according to both tenets should result in the highest integrity device trial that affords the most stringent level of protection for human research subjects.  While this may be challenging, it can be accomplished with hard work and proper preparation.  Ensuring trials comply with both sets of standards allows companies that conduct international trials to feel confident that the resulting data is acceptable not only in the US, but also to worldwide regulatory agencies. 

Please take time to download our new whitepaper and let us know your thoughts.

FDA Regs vs ISO Whitepaper

Topics: Federal Regulations, ISO 14155, CFR 21, IMARC Research Whitepaper


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