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FDA Issues Final Guidance on Intent to Exempt Certain Medical Devices from Premarket Notification Requirements

On July 1, 2015 the FDA issued its final guidance regarding the intent to exempt certain unclassified medical devices, certain Class II medical devices, and certain Class I medical devices that are subject to the reserved criteria of section 510(l) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360(l), from premarket […]

| 5 min read

Product Recall Trends in 2015

What are the latest trends on product recalls in the United States? Stericycle ExpertSOLUTIONS writes an interesting and informative quarterly report on this data, and its detail on the first quarter of 2015 is here. Consumer Products. The Consumer Product Safety Commission has been proactive in recent years with consumer product regulations and recalls, particularly […]

| 2 min read
KW
Former Partner

FDA Issues Draft Guidance on Distributing New Risk Information for Approved Drugs and Biologics

In June 2014, the U.S. Food and Drug Administration (FDA) issued a draft guidance for the distribution of new risk information for approved prescription drugs to healthcare professionals and healthcare entities. The draft guidance, entitled Guidance for Industry Distributing Scientific and Medical Publications on Risk Information for Approved Prescription Drugs and Biological Products—Recommended Practices, establishes […]

| 4 min read

FDA Issues New Draft Guidance on Medical Device Data Systems

On June 20, 2014, the Food and Drug Administration (FDA) issued draft guidance advising that the agency does not intend to enforce compliance with the regulatory controls that apply to medical device data systems, medical image storage devices and medical image communications devices, due to the low risk they pose to patients. The guidance, titled […]

| 3 min read

Drug and Device Manufacturers Beware: Comments Could Result in FDA Troubles

After appearing on CNBC television show Fast Money, the CEO of Aegerion Pharmaceuticals received a warning letter from the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion.  The agency asserted that comments made on the show constituted promotional speech and resulted in Aegerion’s cholesterol lowering drug, Juxtapid, being misbranded. According to […]

| 2 min read
LW
Former Proposals Specialist

Ten Things to Know About the New Unique Device Identifier Rule for Medical Devices

Reprinted with the permission of the Record Reporter, originally printed as “The Future of Medical Recalls” on November 15, 2013. Many medical devices will soon carry a unique identity code, under a new rule recently published by the U.S. Food and Drug Administration (FDA). The FDA refers to this as the Unique Device Identifier (UDI) rule. A […]

| 6 min read
KW
Former Partner

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
KW
Former Partner