Home News & Events News overview As of TODAY you can collect clinical device data for your IDE or PMA outside of the USA

Joris Bannenberg

CMO & Medical Director

February 22, 2019

As of TODAY you can collect clinical device data for your IDE or PMA outside of the USA

A year ago, the FDA published their final rule on the acceptability of medical-device clinical data collected outside of the USA (OUS) to support an IDE or device marketing application (1). Published in February 2018, the effective date of the rule is February 21st 2019! In other words: as of now you can start using medical-device clinical data from trials conducted outside of the USA for IDEs, PMAs, etc.

Of course, there are a few restrictions! The most important of which include the following:

  • The trial has to be conducted according to ‘a’ GCP that is acknowledged by the FDA. The regulation, ISO14155:2011 (which is the most up-to-date GCP for medical device trials), has been recognized by the FDA since 2012 as acceptable.
  • The GCP/ISO14155 requirement means thatthe sponsor has to show that they had control over the clinical data, not only after the study but certainly also during the study (e.g. data-management and monitoring)!
  • The participating investigators have the right qualifications and experience, as well as training on GCP and the medical device. Note that the medical device might be ‘post-market’ in the OUS-region but ‘investigational’ in the USA.
  • The ‘usual’ GCP qualifications and requirements from Independent Ethics Committee have to be known (e.g. names and address, copy of IEC approval, etc.)
  • A full Clinical Investigational Plan (CIP aka study protocol) including proper Informed Consent procedures and a full Clinical Study Report.
  • The FDA should be able to validate the clinical data through an on-site inspection(s).

  • This means that, with the FDA’s implicit consent, medical device sponsors have the opportunity to run their IDE medical device studies not solely in the US but to start earlier in other countries. Our experience has proven that this provides a huge opportunity for medical device sponsors. Our clients who have started their studies OUS have oftentimes benefited from far-lower patient recruitment costs and faster enrollment times, resulting in huge time and cost gains. This is not to make the argument that you should do your IDE/PMA study exclusively OUS (you probably want a few of those US-sites involved), but a well-balanced mix of global investigational sites can provide you with a faster and lower cost track to the US market.

    In order to do this, you will need a medical device CRO that can provide you with the right advice and necessary experience and has the global resources available in the local regions. Why not contact us?

    • Federal Register /Vol. 83, No. 35 /Wednesday, February 21, 2018 /Rules and Regulations page 7385-7388

    About the author

    Joris Bannenberg CMO & Medical Director

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