FDA Considers Meeting With Firms Before Ordering Section 522 Studies
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
Shuren Touts Pre-Market Benefits Of Planned National Post-Market Strategy
CDRH is drafting a national comprehensive post-market strategy, due out this spring. While a principle goal is catching safety problems earlier, Jeffrey Shuren hopes the plan will ultimately make data collection less burdensome for industry, both in the pre-market and post-market stages.
FDA Emphasizes Efficiency In 522 Surveillance Order Draft Guidance
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between regulators and device companies targeted by the agency in Section 522 post-market surveillance orders in a draft guidance issued Aug. 16.
FDA May Impose More "522" Studies As Post-Approval Enforcement Tool
FDA says it will more frequently use its authority to mandate so-called Section 522 post-market studies when companies fail to meet their original post-approval study requirements - and this time, the idea might actually stick