Summary of FDA Guidance on Mobile Medical Apps

Overview On September 25, 2013, the FDA issued its final guidance explaining how it plans to regulate mobile medical applications, or “apps,” under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance clarifies which mobile apps will be … Continue reading

Posted in FDA, guidance, medical, medical devices, mobile

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Personal Injury Claims Escape Preemption Defense in Medical Device Case

The District of Arizona recently denied a motion to dismiss by Medtronic Inc., rejecting the argument that federal law preempted a plaintiff’s personal injury claims related to a product that had obtained premarket approval. Infuse is a bio-engineered liquid bone … Continue reading

Posted in FDA, medical devices

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Product Recall Trends and How to Prepare for a Recall

Product recalls are more common than ever.  We see recall announcements virtually every week.  Consumers have come to expect them, and to expect that companies will act quickly and decisively when a product risk is identified. Most recalls today are … Continue reading

Posted in consumer products, CPSC, FDA, food, medical devices, pharmaceutical, products, recalls

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The FDA’s 510(k) Approval Process in Medical-Device Litigation

Originally published in the American Bar Association, Product Liability Section of Litigation, Vol. 24 No. 2 (Summer 2013). Any litigator knows evidence makes or breaks a case. One piece of admissible evidence may not determine a matter outright, but it … Continue reading

Posted in litigation, medical devices

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