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Understanding the FDA's New Importer Guidance For Devices - Part of a broader effort to place more responsibility for quality control on manufacturers, this guidance is the FDA's roadmap for producing safe products. Learn how to meet or exceed the agency's important new requirements.
Background: The FDA has had many challenges and setbacks in the past few years. From budget cuts, to high-level departures, the agency has also faced fury from lawmakers on Capitol Hill over high-profile device, drug and food recalls.
Off the record, current and former FDAers have told us that they know they’ve been understaffed and underfunded in recent years, and that their enforcement capabilities often weren’t up to the task.
Now with a new president and renewed focus on government regulation in Washington, it’s likely pressure from the White House and Capitol Hill will spur the agency to be more active this year and in the next several years, experts say.
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