Assessment of Data Sources That Support US Food and Drug Administration Medical Devices Safety Communications.

ABSTRACT:

Importance

Medical Device Safety Communications (MDSCs) are used by the US Food and Drug Administration (FDA) to convey important new safety information to patients and health care professionals. The sources of initial safety signals that trigger MDSCs have not been described previously.

Objective

To assess the sources of initial safety signals that trigger publication of MDSCs and the potential associations among MDSC data source, type of safety issue, and subsequent FDA action.

Design, setting, and participants

In this cross-sectional study, all MDSCs published on the FDA website between January 1, 2011, and December 31, 2019, were assessed. The MDSC characteristics, sources of initiating safety signals, regulatory approval or clearance pathways of the related medic

SUBMITTER: Tau N 

PROVIDER: S-EPMC7522775 | biostudies-literature | 2020 Nov

REPOSITORIES: biostudies-literature