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BioWorld - Tuesday, March 31, 2026
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Home » Deadlines a sticking point in FDA’s Section 522 studies draft guidance
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Deadlines a sticking point in FDA’s Section 522 studies draft guidance

Jan. 27, 2022
By Mark McCarty
The U.S. FDA often has difficulty turning around draft guidances into final guidances in a timely manner, but that hasn’t impeded the agency’s appetite for fast turnaround of industry responses to FDA mandated postmarket surveillance studies. Nonetheless, the Medical Device Manufacturers Association (MDMA) said in comments to the docket for the May 2021 draft guidance for Section 522 postmarket surveillance studies that a requirement that such a study be fully enrolled within 24 months should be aspirational rather than compulsory.
Medical technology Regulatory U.S. FDA

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