Extract
In the so-called evidence-based medicine (EBM) era, pre-market clinical trials showing equivalent or superior benefit from new drugs versus existing therapies are required by regulatory bodies, while the process for approval of medical devices is less stringent [1]. The expansion of device-based therapies for cardiovascular conditions makes cardiology the ideal setting for analysing the peculiarities of this process [2].
Abstract
Lessons learned from cardiology: the process for approval of medical therapeutic devices must be redesigned http://ow.ly/bJPm3017ySH
Footnotes
Conflict of interest: Disclosures can be found alongside this article at err.ersjournals.com
Provenance: Submitted article, peer reviewed.
- Received April 21, 2016.
- Accepted May 24, 2016.
- Copyright ©ERS 2016.
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