Devices

Inspectors Find Invacare Not Meeting Decree Terms

A five-month inspection at Invacare, Elyria, OH, found that the company is not living up to terms of a consent decree for its wheelchair manufacturing operations signed with FDA in 2013, a Crain’s Cleveland Business report says. An FDA-483 listed the inspection period as 7/16/15 to 12/9/15. Inspection observations in the 483 included:
deviation from the procedural requirements of a decree of injunction by not implementing specific decree protocols; inadequate design control risk analysis; design verification does not confirm that design output meets design input requirements; design validation did not ensure that the device conforms to defined user needs and intended uses;· design input requirements were not adequately documented; inadequate documentation of monitoring and control methods and data for a validated process; and inadequate documentation of process validation activities.

The injunction decree required the company to stop manufacturing, designing, and distributing manual and powered wheelchairs and their components. At the time, FDA said that seven inspections since 2002 documented violations of Quality System regulations and failing to properly report adverse events to the agency.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome