Devices & Diagnostics Letter

FDA-industry negotiations to reauthorize the Medical Device User Fee Act (MDUFA) went down to the wire last week, as CDRH seemed destined to miss a Jan. 15 due date for sending a commitment letter to Congress.

Surgical mesh manufacturers have until Feb. 3 to submit their plans to the FDA for conducting postmarket studies under Section 522 of the 1938 FD&C Act.

Thoratec could lose its dominance in the U.S. left-ventricular assist device (LVAD) market this year if the FDA approves competitor Heartware’s LVAD pump, analysts say.

Confusion stemming from the recent media blitz about faulty breast implants made by a defunct French company underscores the need for a new regulatory framework for medical devices in Europe, industry group Eucomed says.

Devicemakers doing business in Australia are criticizing a Therapeutic Goods Administration (TGA) report on regulatory reform that fails to endorse a common industry conduct code.

The U.S. Supreme Court could choke off one mechanism devicemakers and other medical companies use to appeal patent denials in a case argued last week.

The FDA has issued a warning letter to Johnson & Johnson subsidiary Animas for repeated failure to report adverse events with its insulin pumps.

The FDA has granted 501(k) approval for Smith & Nephew’s single-use negative pressure wound therapy (NPWT) device.

The U.S. Court of Appeals for the District of Columbia has reaffirmed a lower court decision that FDA warning letters are not final agency actions, so companies cannot seek judicial review of them under the Administrative Procedures Act.

Despite lingering efficacy concerns, an FDA advisory panel voted to recommend approval of a PMA for Torax Medical’s implantable LINX reflux management system.