As per U.S. Food and Drug Administration (FDA) rules, anyone planning to manufacture or distribute a medical device within the United States must either obtain premarket approval (PMA) or complete a 510(k) submission for that device. Either way, the specific …
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  On April 12, 2019, children’s toy company Fischer-Price announced they are in the process of recalling 4.7 million of their Rock ’n Play sleepers. The United States Consumer Product Safety Commission (USCPSC) posted a recall notification on their website …
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An In Depth Look At The Xarelto Case Johnson & Johnson and Bayer, who were recently sued as part of several mass tort litigations on both state and federal levels, have agreed to pay $775 million to settle approximately 25,000 …
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FDA Moves On Surgical Stapler Malfunctions Surgical staplers and implantable staples are used in a variety of surgical procedures, including gynecological surgery, gastrointestinal surgery, appendectomies, lung surgery, heart surgery, and thoracic surgery. Compared to manual suturing, surgical staplers and staples …
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