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Medtech regulatory news for the week of Mar. 17, 2014

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U.S. FDA considering new requirements for off-label use data

March 12, 2014 by MassDevice

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By Stewart Eisenhart, Emergo Group

US regulators have published updated draft guidance on recommendations for distribution of scientific and marketing materials related to unapproved uses of medical devices, drugs and other products under Food and Drug Administration oversight. The agency is accepting public comments on the guidance through April 2014.

Revising guidelines originally issued in 2009, the FDA has now developed recommended best practices for manufacturers providing information to medical or scientific publications that discuss unapproved uses for devices already registered for sale in the US. Read more

Another warning letter for Hospira

March 12, 2014 by Arezu Sarvestani

Another warning letter for Hospira

Infusion technologies maker Hospira remains in the FDA’s cross-hairs after agency inspectors asked for more information about a North Carolina manufacturing facility that has been in hot water for years.

In the new warning, FDA officials cited at least 1 device malfunction in the field associated with injection systems that failed leak testing but were nonetheless allowed on shelves. One of the devices in the product lot was labeled “non-conforming” during October 2012 testing, but that failure was deemed unrepresentative of the batch and the devices were sent to market anyway, inspectors said. Read more

SafeOp Surgical lands FDA nod for neuromonitoring device

March 13, 2014 by Brad Perriello

SafeOp Surgical lands FDA nod for neuromonitoring device

SafeOp Surgical said it won 510(k) clearance from the FDA for its EPAD neuromonitoring device.

The Stamford, Conn.-based company develops technology used to detect peripheral nerve damage caused by nerve compression or stretching. Read more

Boston Scientific's Ingevity MRI-safe cardiac pacing leads win EU nod

March 14, 2014 by Brad Perriello

Boston Scientific's Ingevity MRI-safe cardiac pacing leads win EU nod

Boston Scientific said it won CE Mark approval in the European Union for its Ingevity pacemaker leads, designed to be safe during MRI scans.

The Natick, Mass.-based medical device company said it’s already launched the Ingevity leads in countries that recognize the CE Mark. Read more

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