Finnish X-Ray Company Oy Ajat Gets FDA Warning Over Procedures
The FDA has warned a Finnish maker of x-ray devices that the agency says lacked procedures on design control, quality audits and training. Specifically, the company's internal quality audit procedure did not have requirements for reauditing deficient areas, according to the April 10 warning letter posted recently online. Post-inspection, the company updated its procedure, describing steps for conducting reaudits. However, it did not provide a systemic corrective action, such as assessing previous internal audits to see if a reaudit is necessary, the letter says. . . . more
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Italian Laser Manufacturer Faulted for Inadequate GMPs
An Italian manufacturer of laser devices was hit with a Form 483 and warning letter after an FDA inspection detected multiple problems with the company's documentation practices. The FDA inspected Fisioline s.r.l.'s Verduno, Italy, facility between Oct. 29 and Nov. 1, 2012, filing a nine-observation Form 483 upon conclusion. A subsequent March 5 warning letter includes a total of 13 violations related to GMPs at the facility, as well as a fourteenth stating the company's products are considered misbranded due to poor MDR procedures. . . . more
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EU May Implement Device Directives Sooner Than Planned, Industry Warned
Manufacturers should brace for changes to European device regulations to be completed far sooner than the 2021 now indicated in official plans, experts indicated Wednesday at the MedCon 2013 meeting here. Paul Brooks, president of notified body BSI Product Services, said there are now significant lobbying efforts to start the transition in 2014. The length of the transition period is currently under debate as well, said Brooks, but could be as short as 18 months for the device regulation and 30 months for the in vitro diagnostic device regulation. . . . more
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FDA Fine-Tuning UDI Final Rule, OTC Exemption May Be Dropped
The FDA's final rule on unique device identification (UDI), due in May or June, will likely not include an industry-backed exemption for over-the-counter medical devices, an FDA official says. The proposed UDI rule would exempt OTC devices to avoid redundancy with UPC codes. But after reviewing stakeholder comments, the agency now believes a blanket exemption for OTC devices "would not be helpful," Jay Crowley, senior advisor for patient safety, said during a February webinar. UDIs were first proposed in the FDA Amendments Act of 2007 and were mandated in last year's Food and Drug Administration Safety & Innovation Act (FDASIA), with roll-out scheduled over the next few years. . . . more
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TTIP Negotiations Should Start By Summer, Device Groups Push to Include Single Audit
Device trade groups are pushing for several harmonization provisions, including a single-audit system, to make it into the planned Transatlantic Trade and Investment Partnership (TTIP) Agreement. Negotiations on the deal are expected to begin this summer or sooner. If industry groups are successful, devicemakers could see a single quality system audit for the U.S. and EU as soon as two years after the TTIP is implemented, according to AdvaMed. . . . more
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Health Canada Suspends All Licenses for IVD Company on Export Worries
Health Canada has recalled all products made by an in vitro diagnostics company while the business resolves concerns over its distribution and export practices. The agency announced recently it was suspending all of IND Diagnostic's medical device licenses, citing concerns about the company's management system for licensed devices and evidence that it imported unlicensed tests into Canada for export to dozens of countries, including Germany, Australia, New Zealand and Vietnam. . . . more
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