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Mid-Year FDA Regulation & Guidance Review

Introduction It is often difficult to stay abreast of the many regulatory changes occurring within the medical device industry, not to mention what they may mean in practice for global manufacturers. To assist with this mission, provided below is a mid-year review of noteworthy U.S. Food & Drug Administration (FDA) regulatory updates and guidance releases … Continued

FDA Issues New Draft Guidance Document for Pre-Submissions

In response to the goals set forth within the 2017 Medical Device User Fee Amendment (MDUFA IV), the U.S. Food & Drug Administration (FDA) issued on June 7, 2018, a new Draft Guidance for Pre-Submissions, intended to replace the September 29, 2017 Final Guidance. Although the Draft Guidance, “Requests for Feedback and Meetings for Medical … Continued