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Fdanewsdevicedailybulletin

Aug. 8, 2012

Vol. 9 No. 155

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MDUFA Reauthorization: Find Out What it Means For You

The reauthorization of the Medical Device User Fee Act (MDUFA) should make some devicemaker interactions with the FDA simpler, though in at least one area it may fall short in improving industry/FDA relations. That’s the initial view of the act from Pamela Forrest, partner at the law firm King & Spalding. “There are a few things that struck me as pretty significant in a positive way for industry,” Forrest said. Streamlining of the de novo process by which moderate risk devices with no predicate can reach the market seems like a win for industry. Under MDUFA changes, devicemakers no longer need to first file a 510(k) submission before petitioning for de novo designation. “Theoretically, there should be a noticeable time decrease in getting a de novo classification or an answer that you’re not getting one,” she said. Read More

Senator: FDA Scientist Email Probe May Have Broken More Laws

A key Republican lawmaker is calling for more thorough government probes into the FDA’s monitoring of nine of its scientists as new information shows the agency may have broken more laws than congressional investigators previously believed. Read More

UK Provides Guidance for Notified Bodies on IVD Self-Tests

Makers of home use medical test kits must be able to demonstrate that they can be properly used by people who lack specialized training, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) says in new guidance for notified bodies. Read More

Volcano Lands Tentative Win in CardioSpectra Lawsuit

Former shareholders of medical device company CardioSpectra, acquired by Volcano in 2007, have another two weeks to correct the defects in a lawsuit seeking some $17 million in milestone payments from Volcano. Read More

FDA Grants 510(k) Clearance to Victus Femtosecond Laser Platform

Bausch + Lomb, the global eye health company, and Technolas Perfect Vision GmbH, a leading ophthalmology laser company, announced today that the Victus Femtosecond Laser Platform received 510(k) clearance from the FDA. Read More

Pananomics Obtains CE Certification for Digital X-Ray

X-ray manufacturer Pananomics obtained CE Mark certification for the digital X-ray “Wise-DR Chest” and “Wise-DR Multi.” Read More

Defibrillators Cut Cardiac Death by Third

Implantable cardioverter defibrillators reduced cardiac arrests caused by ventricular fibrillation by one-third in the Northern Netherlands, researchers say. Read More

Sensor Uses Body’s Electrical Signature to Secure Devices

A group of researchers is proposing a sensor that would authenticate mobile and wearable computer systems by using their unique electrical properties of a person’s body to recognize their identity. Read More

Planned Manufacturing Facility Expansion

Diversified Plastics officials plan to expand its manufacturing location in Brooklyn Park, Minn. Read More