FDA Law Blog
JUNE 12, 2022
The DOJ notes that “device manufacturers are required to investigate adverse events and report information to the FDA within 30 days of becoming aware of information that the marketed device “[h]as malfunctioned. . . The increased number of reports would likely swamp FDA’s data systems, creating even more signal to noise than already exists.
The Process Street
JANUARY 1, 2024
These solutions may incorporate elements of quality management as part of broader regulatory compliance frameworks, particularly in highly regulated industries like pharmaceuticals and healthcare. It offers a wide range of features tailored to meet the needs of various industries, including manufacturing, healthcare, life sciences, and more.
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FDA Law Blog
JANUARY 5, 2023
It is another effort from CDRH’s Digital Health Center of Excellence to provide structure and guidance to participants across the connected device playing field, including both delivery organizations as well as manufacturers. Digital providers and manufacturers not only have the concerns of the FDA to consider, but those of the FTC as well.
The Process Street
OCTOBER 4, 2021
While gathering quality consumer data is essential for the contemporary organization, data analytics has another equally important role to play: people management. There are four main categories you need to think about for an effective analytics framework: Enablers, Deliverables, Stakeholder Management, and Governance.
FDA Law Blog
OCTOBER 10, 2022
Consistent with the 2019 draft guidance, the final guidance also includes textbooks, approved drug or medical device labeling, and government agency recommendations as other permissible types of medical information. Criterion 4: The fourth criterion seeks to ensure that Non-Device CDS does not supplant an HCP’s independent clinical judgment.
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