As required by the Food and Drug Administration Reauthorization Act (FDARA), theFDA has issued a reporton the continued quality, safety and effectiveness of medical devices related to servicing medical devices. As industry associations call on Food and Drug Administration (FDA) to increase regulatory oversight on the servicing of medical devices, a lack of evidence to “justify imposing additional/different burdensome regulatory requirements at this time” caused agency staff to take a different approach, a new report concludes.
Manufacturers that contract third-party services have raised several issues and concerns over the past few years regarding the inadequate handling of devices, urging for regulatory controls in the servicing space.
In a new first-of-its-kind report mandated under section 710 of theFDA Reauthorization Act of 2017 (FDARA), the agency’s Center for Devices and Radiological Health (CDRH) outlined four areas in which it will pursue actions aimed at addressing the device firms’ concerns with a different approach.
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Contact Us WhatsApp新报告中确定的行动包括working in collaboration with servicing firms to establish a voluntary medical device servicing framework to promote the adoption of quality management principles. “We view this strategy, rather than a formal regulatory approach mandating adoption of FDA’s [Quality System] regulation by all entities performing medical device servicing, as the appropriate approach at this time for advancing the quality of medical device quality servicing,” CDRH said.
“The currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third-party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time,” FDA states in the report. “Rather, the objective evidence indicates that many OEMs and third-party entities provide high quality, safe, and effective servicing of medical devices.” The agency also concludes that most comments, complaints and adverse events (including deaths) that put the blame on inadequate servicing were instead related to remanufacturing. FDA also believes the role of third-party firms to service and repair medical devices is “critical”.
虽然FDA监管requi建立更多的感觉rements related to servicing isn’t necessary, it plans to carry out several related actions, including promoting the adoption of quality management principles, clarifying the difference between servicing and manufacturing, strengthening cybersecurity practices related to device servicing, and promoting evidence development to assess the quality, safety and effectiveness of device servicing.