Design
Editorial
Key result
Implantable medical device regulation in Europe often relies on short-term studies with surrogate endpoints, transferring the responsibility for proof of safety and clinical efficacy to follow-up.
Authors
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Device approvals relying on short-term surrogates demand post-market vigilance; leaves open the need for extended trials and regulatory harmonization.
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Fraser et al. (2011) reported an editorial. Implantable medical device regulation in Europe often relies on short-term studies with surrogate endpoints, transferring the responsibility for proof of safety and clinical efficacy to follow-up.