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Review times and adverse events for cardiovascular devices.

ABSTRACT: Shorter regulatory review times for high-risk cardiovascular devices correlate with the likelihood of reports of adverse events.

SUBMITTER: Stern AD 

PROVIDER: S-EPMC6597013 | biostudies-literature | 2017 Jan

REPOSITORIES: biostudies-literature

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Review times and adverse events for cardiovascular devices.

Stern Ariel Dora AD   Kramer Daniel B DB   Ouellet Melissa M   Kesselheim Aaron S AS  

Nature biomedical engineering 20170110 1

Shorter regulatory review times for high-risk cardiovascular devices correlate with the likelihood of reports of adverse events. ...[more]

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