Regulation of Devices There are thousands of different medical devices ranging from the most simple, like a surgeon’s glove to complex mechanical devices such as internal cardiac defibrillators. The taxonomy of device classification is an important way for manufacturers and regulators to organize the exceedingly diverse universe of medical devices. To prepare for this Application Assignment, review this week’s Learning Resources regarding the classification of medical devices, how they are classified, and how they are regulated and approved. To complete this Application Assignment, write a 2- to 3-page paper that addresses the following: Differentiate among the different classes of medical devices and give three examples of each. Describe the regulatory requirements for each class of device. Explain the features and differences among these device approval processes: Premarket notification (510[k]), Premarket approval (PMA), and Investigational Device Exemption (IDE). Address to which class of device these requirements correspond and how they are applied. It’s been said that regulation of medical devices is 10 years behind the regulation of drugs. Explain what you think that means, whether or not you believe it’s true, and why. Your written assignments must follow APA guidelines. Be sure to support your work with specific citations from this week’s Learning Resources and additional scholarly sources as appropriate. Refer to the Essential Guide to APA Style for Walden Students to ensure that your in-text citations and reference list are correct.
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