As we discussed in our webinar, 5 Steps to Success for Your Cardiovascular Medical Device Trial, one of the first and most important steps in creating a development program is deciding where your medical device will be initially marketed. While the United States and European Union are the two largest markets for medical devices, substantial differences between the two approval processes require strategic thinking and upfront planning to design an efficient, streamlined program.

During the live event, we asked attendees: For any Class III high-risk CV device trials in-process or on the horizon, are you first seeking approval outside of the US?

The results of our poll:

  • 26 percent said yes.
  • 21 percent said no.
  • 53 percent said not applicable.

Due to shorter technology cycles and significant competition making devices become obsolete faster, it’s not surprising that more than a quarter of participants are looking outside the US to market their devices, where regulatory procedures are often faster and require less clinical and safety data.

In fact, less stringent requirements in the EU (and other parts of the world) prompt some sponsors to seek ex-US approval first and then use accumulated safety and efficacy data to support the initiation of a clinical development program in the US. According to a study analysis in the Journal of the American Medical Association, of the 78 CV devices approved via the FDA premarketing authorization (PMA) process between 2000 and 2007, 36 percent had no US study sites.

However, when seeking approval outside of the US, there are still many things to consider.

  • In general, using FDA standards for safety monitoring, data quality, endpoint definitions, sample size calculations, and duration of follow-up is likely to be acceptable to regulatory bodies in other nations.  Be aware, however, that these standards are constantly in flux.  Trials started today will need to meet the regulatory expectations of the future.
  • Despite widespread compliance with the International Conference on Harmonization/Good Clinical Practices (ICH-GCP) requirement that every trial be reviewed and approved by an institutional review board or ethics committee, there may be additional local requirements regarding provisions for standard of care, post-study access to medications, and minimum insurance coverage levels for each enrolled patient.
  • Some countries, including China and Japan, require clinical testing in local patient populations prior to product registration.
  • Standards of care may differ when conducting multinational trials including, but not limited to, the use of background medications and rates of reported adverse events.
  • Standards for diagnosis also vary across regions, and sponsors should consider local requirements for diagnostic testing and/or imaging and validate radiology and other technical equipment before study initiation.

For more information on differences between the marketing approval processes for the United States and the European Union or on other key issues in the clinical development for interventional cardiovascular devices, feel free to download the slides and be on the lookout for an upcoming eBook.  If you’d like to be alerted when the eBook is available, please leave your contact information in the comments section.