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50 PCB007 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 Under- writers Laboratories (UL) and Conformité Eu- ropéene (CE, also known as European Confor- mity). Most medical device developers will ad- mit that achieving FDA approval can be a big hurdle on the way to new product introduc- tion (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 ex- isting products, and so much more. Michael Lynch, quality manager at Libra In- dustries in Mentor, Ohio, offered a brief expla- nation of FDA device classifications. "Everything is risk-based. The FDA uses three main regulatory classes to group medical devic- es: Class I, Class II, and Class III. Class I devic- es require the lowest level of regulatory control because they present the lowest level of risk in the form of a low probability of causing 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 as- surance that they will perform without caus- ing harm to the patient than Class I," he con- tinued. "If a Class II device fails, there is a low risk of causing serious injury to the patient. Blood pressure monitoring equipment is a typ- ical example of a Class II device. Though, be- cause patients and staff may be depending upon these devices for feedback, Class II devic- es are designed and constructed to a high level of assurance that the device will work proper- ly. Class III includes critical care and life sup- port. A malfunction in a Class III device can cause serious injury or death." Based on the class of the product differ- ent pathways, objective evidence and require- ments may be necessary. For example, one of- ten-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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