Medtronic’s Recent Interactions with the FDA

It has been a busy couple of months between Medtronic and the Food and Drug Administration (FDA), with Medtronic experiencing both recalls and approvals from the government agency.  Below is a brief summary of some recent of Medtronic’s recent interactions with the  FDA.

First, in early April, the FDA announced that Medtronic was notifying customers of a voluntary field corrective action for its Newport HT70 and HT70 Plus ventilators over the potential for unexpected shutdowns, which it believes are due to software issues in the devices.  MassDevice reports that is recalling well over 7,000 of the affected devices.

Next, the FDA cautioned healthcare providers against using Medtronic’s NavLock Tracker with instruments not cleared to be used with the device.  The NavLock Tracker is an accessory to Medtronic’s StealthStation navigation system for use during spinal fusions.  As a result, Medtronic is updating its labels on the devices to indicate that only Medtronic instruments should be used.

In early May, Medtronic received official FDA approval for a new drug-eluting stent (DES) known as Resolute Onyx.  According to FierceBiotech, the stent is formed from a single strand of a cobalt alloy wire with a platinum-iridium core and can provide physicians with stent sizes up to 4.5-mm and 5.0-mm.  This newly approved stent is available for use in the United States, Europe, and countries that recognize the Conformité Européene (CE) mark.

In addition, Pat Shrader, Medtronic’s Vice President of Global Regulatory Affairs, appeared on Capital Hill to request changes in device manufacturing facility inspections by government officials due to the short notice that the manufacturing facilities receive prior to inspection.  Shrader was speaking on behalf of the Advanced Medical Technology Association, which includes other companies such as 3M, St. Jude Medical, and Boston Scientific.  Ms. Shrader called for standardization of inspections by the FDA.

Dan Fischer
Dan Fischer is an associate at our New York office. In his practice, Mr. Fischer assists clients large and small in various technological fields including metals/alloys, polymers, composites, medical devices, semiconductors, oil pipes, catalytic converters, and building construction. Mr. Fischer received his J.D. from the University of Southern California. During law school, he worked in the USC IP and Tech clinic. Before attending law school, Mr. Fischer attended the University of Illinois and received a B.S. in Materials Science Engineering with concentrations in biomaterials and polymers. Mr. Fischer also worked in the Materials Lab at FermiLab. Mr. Fischer worked as a summer associate at the firm in 2010 and joined the firm as an associate in 2011.
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