In our recent 5 Steps to Success for Your Cardiovascular Medical Device Trial webcast, attendees shared that regulatory considerations are the biggest issue they face with regards to clinical development of high-risk interventional CV devices.

This came in response to the following attendee polling question: What do you consider the biggest issues facing clinical development for high-risk interventional CV devices?

  • Regulatory considerations: 48 percent
  • Operational considerations: 20 percent
  • Data management and monitoring: 16 percent
  • Global standards of care: 16 percent

A first step in creating a successful development program is deciding where the device will be marketed. For high-risk interventional CV devices, current EU procedures are almost certainly faster and require less clinical and safety data than the more rigorous US Food and Drug Administration technical standards and requirements.1 This prompts 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.1   Of course, data generated in the US also may be used for device approval in other countries.

With careful planning, it is also possible to gain FDA approval for a device using data collected outside of the US.  In fact, an analysis of 78 CV devices approved via the FDA premarketing authorization (PMA) process between 2000 and 2007, found that 36 percent had no US study sites2.

Monitoring graphics

As outlined on the FDA’s website – premarketing authorization (PMA) based solely on foreign clinical data and otherwise meeting the criteria for approval under this part may be approved if:

  • The foreign data are applicable to the U.S. population and medical practice;
  • The studies have been performed by clinical investigators of recognized competence; and
  • The data may be considered valid without the need for an on-site inspection by FDA or, if FDA considers such an inspection to be necessary, FDA can validate the data through an on-site inspection or other appropriate means.

If you are interested in learning the key considerations that must be addressed when planning your regulatory strategy, please watch the recorded webcast.  Additionally, we will be releasing an ebook on the topic.  If you’d like to be alerted when it becomes available – simply leave your contact information in the comments section.


  1. Fraser AG, Daubert JC, Van de Werf F, et al. Clinical evaluation of cardiovascular devices: principles, problems, and proposals for European regulatory reform.  Eur Heart J. 2011;32:1673-1686.
  2. Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by FDA in premarket approval of cardiovascular devices. JAMA. 2009;302:2679-2685.

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