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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[1] will be regulated by the FDA and who will be required to comply with the regulations. The […]

| 8 min read

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 graft substitute.  It is classified as a Class III device under the Medical Device Amendments […]

| 3 min read

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 voluntary and move very rapidly.  Here are some observations about 2013 recall trends. Pharmaceutical/Drug.  Pharmaceutical […]

| 4 min read
Former Partner

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 may be that crucial nudge for a jury to tip the scales of justice for […]

| 11 min read