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Regulatory/Compliance

UPDATE: CDRH chief Shuren blasts Stanford study on medical device regulations

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Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles.

Shuren told MassDevice that a study by researchers at Stanford University titled “FDA Impact on U.S. Medical Technology Innovation,” which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was “highly flawed.”

FDA falls short of business, public’s expectations

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Industry and the American public have lost faith in the federal agency in charge of overseeing the country’s drug and medical device industry, according to an annual survey by PricewaterhouseCoopers LLP.

PWC and Biocom, a trade association representing 550 California life science firms, interviewed 1,000 individuals and executives at 50 medical device, drug and diagnostic companies. The pollsters found that slightly more than half (51 percent) expressed a favorable opinion of the Food & Drug Administration’s performance, but that high-profile drug recalls had damaged confidence in the watchdog agency.

Advanced Bionics recalls hearing implant

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Advanced Bionics recalled its cochlear hearing-aid implants.

The subsidiary of Staefa, Switzerland-based Sonova Holding AG (SIX:SOON) received reports that is HiRes 90K cochlear implant device had malfunctioned eight to 10 days after it was activated. Two patients suffered from pain and loud noise, according to the company.

Advanced Bionics notified the Food & Drug Administration of the problem and its working with the agency to rectify it.

FDA’s former 510(k) chief lukewarm on proposed changes

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The Food & Drug Administration’s proposals to re-vamp its most-used medical device clearance protocol are a mixed bag, according to the agency’s former staff director for the program.

Heather Rosecrans, now a regulatory adviser at the healthcare consulting firm Greenleaf Health LLC, told the audience at the Cooley LLP Medical Device Conference in Boston that she’s skeptical of one new feature in particular: the Centers for Devices and Radiological Health’s proposal to create a new Class IIb designation, which would require clinical data.

FDA and NIH investigate artificial pancreas to combat diabetes

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The Food & Drug Administration and the National Institutes of Health are planning a public hearing to determine if an artificial pancreas can help in the fight against diabetes.

One of the pancreas’ jobs is to regulate insulin levels in the bloodstream, but if the organ doesn’t function correctly, diabetes can result. A future solution to the disease that 171 million people suffer from worldwide may be to develop an artificial pancreas, according to the World Health Organization

FDA: Human error to blame in CT scan overexposures

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The Food & Drug Administration said today that reports it investigated of overexposure to radiation during CT scans were likely due to human error, not malfunction.

The federal watchdog agency also issued recommendations for CT scan equipment makers aimed at reducing the risk of overexposure. The scanners could be made safer if their manufacturers provided more training to end users and the devices included radiation gauges and alarms indicating possible overexposure:

FDA extends user fee review by two weeks

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The Food & Drug Administration extended the comment period on its medical device user fee program until Nov. 1.

On Oct. 1, the FDA boosted the user fees medical device makers pay for applications for clearance or approval from the federal watchdogs. The new fee schedule instituted an across-the-board hike of 8.5 percent. Companies must pay an initial fee of $2,179 to register with the FDA.

FDA plans to revoke ReGen’s Menaflex 510(k) clearance

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The Food & Drug Administration decided it was wrong to clear a knee implant made by ReGen Biologics Inc. (OTC:RGBO) in 2008, over-riding the objections of FDA reviewers.

The rescission means Hackensack, N.J.-based ReGen has to keep its Menaflex device off the market until it can prove its safety and effectiveness to the FDA’s satisfaction.

FDA issues Class I recall of CareFusion Alaris PC infusion units

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The Food & Drug Administration classified the recall of approximately 17,000 CareFusion Corp. (NYSE:CFN) Alaris PC infusion units as a Class I recall.

That’s the most serious level of product recalls for the federal watchdog agency, indicating a reasonable probability that the use of the recalled product "will cause serious adverse health consequences or death," according to the FDA.

FDA deputy Sharfstein: We need to improve accountability

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Dr. Joshua Sharfstein, deputy commissioner of the Food & Drug Administration, told packed house at Harvard Medical School last night that the agency has a ways to go in providing accountability for its decisions.

"A lot of the accountability right now, frankly, comes from me or [FDA head Dr. Margaret] Hamburg," Sharfstein said. "If someone says something that doesn’t make sense, we’ll push them on it and there will be a whole of hand-wringing, but I wouldn’t tell you that we’re where we want to be."