MDDI_Medical Device & Diagnostic Industry

MDDI, July 2016

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MD + DI MEDICAL DEVICE AND DIAGNOSTIC INDUSTRY july 2016 | 25 PlasticsOne Designing components. Engineering life. ® As a progressive USA Contract Manufacturer, we work with OEMs worldwide to create custom JHISLHZZLTISPLZMVY`V\YZWLJPÄJHWWSPJH[PVUZ ISO 13485:2003 and ISO 9001:2008 ISO 10993-5 cytotoxicity certified Fast, tack free cures Sterilization resistant Optically clear compound Hackensack, NJ 07601, USA ∙ +1.201.343.8983 ∙ Cures at the Speed of Light Cures at the Speed of Light LED curable system USP Class VI Approved Adhesive LED403Med USP Class VI Approved Adhesive LED403Med discussed by patients and clinicians before the sterilization procedure. Bayer said at the time that it will work with the agency to sup- port safe, effective use of Essure. Changes Coming to Combination Products regulations In April, FDA announced it was creating the Combination Products Policy Council, a group that will make decisions on combi- nation products, product classification, and cross-labeled products. The move followed other steps the agency has taken to update combination products review, a process that has been criticized as confusing, with complexity in meeting the different require- ments and timelines of each product center. In fall 2015, FDA examined the process and found it suffered from different review and tracking systems at each center, a lack of re- sources, and a need for better communica- tion between centers. The agency has also said it is using lean management process mapping to find problems and create an optimized process. Eu updates IVD, Device rules In late May, the EU reached an agreement on updates to its IVD and medical device regulations. Among the many changes is the requirement that all device manufac- turers doing business in Europe have a risk management system, narrower allowance of evidence based on equivalent products, a shift for notified bodies from partners to policing roles, and required inclusion of Unique Device Identification codes on all device labels. The new rules are expected to be implemented in late 2019 or early 2020. 3-D Printing Draft Guidance As 3-D printing has become more ubiqui- tous in the medical device industry, FDA has stepped in and issued draft guidance on ad- ditive manufacturing (AM) in devices. The draft guidance covers design and manufac- turing considerations as well as device test- ing considerations. The document gives de- vice companies a better idea of the agency's view on 3-D printing, but as experts Hogan Lovell wrote in MD+DI, it "also stops short of clearly addressing many key questions raised by the use of AM in medical devices, such as where one draws the line between the manufacturing process and the regulat- ed device, considerations for point-of-care manufacturing, or who should be consid- ered the 'manufacturer' of the finished de- vice under different scenarios." Progress on National Medical Device Evaluation System Earlier this year, a planning board report set a six-month deadline on the selection of a coordinating center and interim execu- tive director to develop the National Medi- cal Device Evaluation System. From there, a governing board and expert committees are expected to be in place within a year, a device evaluation clearinghouse should be public after two years, projects on safety surveillance and device efficacy evidence development completed by year three, and another slate of projects finished within five years. Marie Thibault is MD+DI's associate editor. Reach her at 2

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