FDA Emphasizes Efficiency In 522 Surveillance Order Draft Guidance
This article was originally published in The Gray Sheet
FDA is emphasizing the need for “early and ongoing” interaction between regulators and device companies targeted by the agency in Section 522 post-market surveillance orders in a draft guidance issued Aug. 16.
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The agency has issued a final guidance on Sec. 522 postmarket study orders about five years after a draft version. In the interim, Congress stipulated a 15-month deadline for companies to start the FDA-mandated studies, a requirement emphasized in the new document.
FDA’s device center seems agreeable to the concept of “pre-522” study meetings, raised by industry last week as a means to make the post-market study order process more efficient.
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