Regulatory
SEC Drops Wright Medical Investigation
Wright Medical Group will not face any enforcement actions from the Securities and Exchange Commission related to foreign sales practices. The SEC’s Division of Enforcement dropped its informal investigation of the medical device maker, according to a government filing. Wright...
Confusion Surrounds FDA Handling of Steris Product
Are endoscopes labeled for use with the Steris Corp. System 1 sterile processing system misbranded? That's what endoscope manufacturers want to know. According to MedCity News, FDA sent a letter to endoscope makers on February 22 that urged them to change their labeling if it...
FDA Voices 510(k) Limitations
At a public meeting on February 18, FDA said that when evaluating devices for 510(k) clearances, it is difficult to compare new products to those already approved, according to Reuters. Heather Rosecrans of FDA said that it may be necessary to develop clearer guidelines or add more...
Is Healthcare Reform Possible?
The State of the Union left many Americans unclear about the state of healthcare reform. Was Obama pledging to continue the fight? Proposing a scaled back healthcare bill? Or moving on to more palatable priorities such as tax cuts for the middle class?   Regardless of Obama's...
Got Something to Say About the 510(k)?
From the wires:   The U.S. Food and Drug Administration announced today that it has scheduled a public meeting on Feb. 18, 2010, to discuss key challenges related to the premarket notification, or 510(k) process, used to review and clear certain medical devices marketed in the...
CMS Payment Limits Spell Opportunity for Biomaterials
The new CMS doesn't reimburse for nosocomial infections. But the new rules can provide device and diagnostics companies with an opportunity to develop new products that help hospitals eliminate risk. For example, a release from TyRx announced the launch of an implantable...
Next Up: Biocompatibility Testing for Stents
FDA News reports that manufacturers of coronary drug-eluting stents should provide the results of biocompatibility tests of the bare-stent platform. The edict comes from a final guidance by the European Medicines Agency’s (EMEA) Committee on Human Medicinal Products. According to...
Heparin Update: 11 Deaths Linked to Devices
Heparin used to clean intravenous lines has been linked to 11 deaths and more than 80 reports of harmful side effects, reports Bloomberg news. However, the problems may not all be caused by contaminated product, Karen Riley told Bloomberg. The heparin associated with two of the 11...
Gathering Biocompatibility Data
During MD&M West, consultant Phil Triolo discussed the challenges of coated devices and combination products. Specifically he covered meeting both technical and regulatory requirements for these types of products. Triolo had several pieces of advice for achieving such goals....
Conference Report: Materials Characterization
NAMSA's Davide E. Albert recently spoke at MD&M West. Among other topics, Albert discussed the importance of characterizing materials for medical devices. Characterization is the process that describes the nature of the materials. It includes chemical, toxicology, physical,...