FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance

On 20 November 2018 Food and Drug Administration (FDA) Commissioner Scott Gottlieb and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren released a joint statement regarding updates to the Medical Device Safety Action Plan (safety plan) announced in April.

The FDA's statement, released after receiving and reviewing public feedback, reiterates and embellishes on certain aspects of the safety plan, including areas of recent progress, while also providing some new information related to the monitoring of a number of device types for women's health. Issuance of the joint statement came shortly before the FDA issued another joint statement regarding the 510(k) premarket review pathway, and both statements come on the heels of increasing scrutiny of FDA postmarket controls for medical devices in protecting public health. The joint statement provides an overarching vision of how the FDA sees the role of postmarket surveillance, but it does not provide details related to how these actions will directly affect the medical device industry, patients, or other stakeholders.

Read More: FDA statement underscores continued emphasis on use of real-world evidence in active postmarket device surveillance


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