Devices & Diagnostics Letter

The FDA appears on track to meet its 510(k) review times for fiscal 2010, but the jury is still out on where it stands on PMAs, the agency says in its annual Medical Device User Fee and Modernization Act (MDUFMA) report to Congress.

A quote from CDRH Director Jeffrey Shuren alleging the EU device regulatory system uses the public as “guinea pigs” has drawn ire from the European Commission (EC) after it appeared in news articles.

After debating into the wee hours of the morning Feb. 19, the House voted 235-189 to pass H.R. 1, the continuing resolution that would fund the FDA through fiscal 2011 at $3.31 billion, cutting about $241 million from the agency’s fiscal 2010 appropriations.

As the FDA’s drug and biologics centers ramp up their regulation of social media promotion, CDRH’s advertising and promotion policy group is, for the most part, continuing to focus on more traditional advertisement venues.

CDRH plans to introduce a prototype this year for a new adverse event database to replace its Manufacturer and User Facility Device Experience Database (MAUDE).

As imaging devicemakers work to get new computed tomography (CT) devices that limit radiation overdoses on the market, a challenging FDA regulatory process has meant that the most innovative changes to CT equipment are being launched elsewhere first.

Zimmer is seeking up to $100,000 in a lawsuit against a group of defendants over internet and television ads that claim its NexGen Knee System “has a high failure rate, causes pain and is otherwise defective.”

The UK has delayed for a second time the implementation of the UK Bribery Act, which outlines criminal offenses for bribery in the commercial sector.

Medtronic is eliminating up to 2,000 positions during the third quarter as part of a major restructuring it blames on softer markets.

With the European Parliament’s consent for enhanced cooperation, a common EU patent system may become a reality.

Tyco Healthcare Canada’s handling of issues cited in supplier corrective action reports (SCARs), such as particles found in syringes, led to a warning letter for the company’s Montreal facility.

The European Commission’s (EC) formal objection to 11 international medical device standards may not mean the harmonizing guidelines are rife with problems, but instead that the system is evolving to become more international instead of focusing on European requirements.

The FDA has warned Anulex Technologies for conducting a clinical trial for its Xclose anular repair device without an approved investigational device exemption (IDE) or adequate investigator agreements.

Eucomed is urging tighter notified body control, rather than a shift from the EU’s decentralized regulatory approach, in upcoming revisions to the EU’s Medical Device Directives.

The FDA has cleared R-Biopharm AG’s norovirus assay, the first test for preliminary identification of the virus, also known as stomach flu.