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FDA Considers Meeting With Firms Before Ordering Section 522 Studies

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.

The device center will consider interacting with device makers before formally issuing Section 522 post-market study orders to speed up the process and let companies prepare for the mandated studies earlier, CDRH officials said last week.

The idea of “pre-522” meetings was discussed at a March 7 FDA workshop in Silver Spring, Md., on the design...

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