Worldwide Medical Device Regulatory Updates

As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.

Stryker Announces Layoffs Ahead of Excise Tax

Medical device manufacturer Stryker Corporation is planning a five-percent workforce reduction through 2012 in anticipation of the Affordable Care Act’s much-maligned Medical Device Excise Tax set to go into effect in 2013.

Stryker expects the move to yield about $100 million in operating cost savings.

Stryker’s announcement is one of the first from a major medical device manufacturer reacting to the pending excise tax with layoffs. But industry advocates and their allies in the US Congress have worked multiple levers in a months-long effort to derail the tax; although the outcome of that effort remains unknown, the likelihood of the tax’s implementation now seems far less certain than it was upon passage of US health care reform in 2010. The question is, are other major medical device industry employers waiting to see whether the excise tax is struck down, or are they also planning staff reductions to offset potential tax liabilities?

Markets: USATags: Affordable Care Act, medical device, medical device excise tax, Stryker

Author: Stewart EisenhartDate: November 15, 2011

FDA Orders Post-market Studies of Metal-On-Metal Hip Replacement Devices

The US Food and Drug Administration has ordered all manufacturers of “metal-on-metal” artificial hip devices to conduct post-market studies to see whether the implants are malfunctioning or causing health problems in patients.

According to a New York Times report, the FDA’s Center for Devices and Radiological Health (CDRH) issued letters May 6 to roughly 20 manufacturers notifying them of the order. Firms will have 30 days to develop their own post-market study proposals and submit them to the regulator; manufacturers will be required to collect data from patients using their devices as well as determine the frequency of device failures. Companies targeted by the order include Johnson & Johnson’s DePuy unit, Biomet, Stryker, Wright Medical and Zimmer.

In the Times article, Dr. William Maisel, deputy director for science at the CDRH, says the action constitutes the largest order of its kind for an approved class of devices. The agency’s move follows increasing reports over the last two years of metal-on-metal hip device failures as well as health problems such as soft tissue damage due to shedding of metallic debris.