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As the life sciences, medtech, and diagnostic industries continue to grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging...more
The U.S. Food and Drug Administration (FDA) today released significant changes to its recommendations for the use of laparoscopic power morcellators in gynecologic procedures, including an update to safety communications...more
On May 22, 2018, the U.S. House of Representatives passed Senate Bill 204, commonly known as the “Right to Try Act of 2017” by a vote of 250-169. The bill gives certain patients with life-threatening conditions the right to...more
The FDA recently published two draft guidance documents to clarify which types of medical software, based on their functionality, are no longer considered medical devices as a result of the changes imposed under section 3060...more