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Dec. 22, 2014

Vol. 41
No. 50


Editor’s Note

Due to the holidays, Devices & Diagnostics Letter will not be published Dec. 29, 2014. Read More

EU Council Hung Up on Premarket Scrutiny Measure, Could Push Regs’ Adoption to 2016

EU leaders are deadlocked over a proposed premarket mechanism for the highest-risk devices, and the stalemate threatens to delay adoption of a major overhaul in device and diagnostic regulations until late next year or even 2016. Read More

Guidance: Passive Implants Must Be Tested for MR, RF-Heating Conditions

Manufacturers of passive implants, such as surgical screws, must begin subjecting products to magnetic resonance testing to see if they become dangerous when exposed to MR systems and radiofrequency heating, the FDA says. Read More

Appeals Court Rules Myriad Can’t Keep Competitors From Market

Yet another court has ruled against Myriad Genetics in ongoing disputes over the company’s patents on tests to detect genes associated with breast cancer. Read More

Philips Bid Spells Relief for Volcano; Edwards, Dexcom Eyeing Strong 2015

Medical imaging maker Volcano was plucked up by Royal Philips for $1.2 billion, just days after Wall Street analysts predicted a rocky year ahead for the San Diego, Calif., devicemaker. Read More

Expert: Expiration Dates, Sampling Tricky With Combo Product GMPs

Devicemakers whose products include a drug component could find GMP compliance especially tricky, due to a 2013 regulation that requires expiration dates like those used for drugs, an industry expert says. Read More

FDA Grants Rare CLIA Waiver for Rapid Syphilis Screening Test

Proof that a diagnostic test could be safely performed by untrained workers convinced the FDA to grant a first-ever regulatory waiver for a syphilis rapid screening assay. Read More

New Zealand Updates Recall Process, Clarifies Roles of Recalling Parties

New Zealand’s regulatory authority is updating its uniform recall procedure for devices, following a recent decision not to pursue a joint regulatory authority with Australia. Read More

India May Ease Foreign Direct Investment in Existing Ventures

The Indian government appears poised to expand foreign direct investment by medtech companies as it searches for ways to beef up domestic manufacturing. Read More

Karl Storz Warned on CAPA, Disinfection Problems

Karl Storz Endovision was handed an FDA warning letter for cleaning slips and other GMP issues related to its endoscopes. Read More

FDA Clears New Tests for Heart Disease, Infant Immunodeficiency

The FDA last week green-lighted a new test for coronary heart disease, saying it could be especially helpful in detecting the condition in African-American women. Read More

FDA Warns Contract Manufacturer for String of GMP, MDR Failures

San Antonio, Texas, contract manufacturer Voss Plastics received a 10-citation warning letter for serious lapses in good manufacturing practices and lack of written procedures for adverse event reporting. Read More

EUnetHTA Guideline Gives Tips on Pooling Dx Accuracy Studies

An umbrella group in the EU is recommending that health technology assessment bodies pool sensitivity and specificity data from multiple diagnostic accuracy studies using one of two methods: hierarchical summary receiver operator characteristic or bivariate random-effects techniques. Read More