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40 SMT007 MAGAZINE I NOVEMBER 2018 Feature by Nolan Johnson I-CONNECT007 Manufacturers of medical electronics have their work cut out for them. These products have to pass approval by the Food and Drug Administration (FDA) in addition to getting the nod from more typical entities such as Underwriters Laboratories (UL) and Confor- mité Européene (CE, also known as European Conformity). Most medical device developers will admit that achieving FDA approval can be a big hurdle on the way to new product intro- duction (NPI). The need to gain FDA approval may seem daunting. Approvals differ depending on so many different variables: classification, new technology or incremental improvement on existing products, and so much more. Michael Lynch, quality manager at Libra Industries in Mentor, Ohio, offered a brief explanation of FDA device classifications. "Everything is risk-based. The FDA uses three main regulatory classes to group medi- cal devices: Class I, Class II, and Class III. Class I devices require the lowest level of regulatory control because they present the lowest level of risk in the form of a low probability of caus - ing injury if they don't work properly. Class I devices are not used to sustain life," said Lynch. "Class II devices require a higher level of assurance that they will perform without caus- ing harm to the patient than Class I," he contin- ued. "If a Class II device fails, there is a low risk of causing serious injury to the patient. Blood pressure monitoring equipment is a typical example of a Class II device. Though, because patients and staff may be depend- ing upon these devices for feedback, Class II devices are designed and constructed to a high level of assurance that the device will work properly. Class III includes critical care and life support. A malfunction in a Class III device can cause serious injury or death." Based on the class of the product different pathways, objective evidence and requirements may be necessary. For example, one often- mentioned FDA clearance is Section 510(k) of the Food, Drug, and Cosmetic Act. According to the FDA code of federal regulation, Section

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