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Which of the following devices are included in Class II devices?(a) Bandages(b) Thermometers(c) Pacemakers(d) Micro ovensThis question was posed to me during a job interview.Question is taken from Controlled Release Medication in division Controlled Release Medication of Drug Biotechnology

Answer»

Correct option is (b) Thermometers

Explanation: FDA has different classes of devices such as Class I includes BANDAGES, GLOVES, Stethoscopes. These have different kind of manufacturing guidelines and PRACTICES which should be followed. Class II devices INCLUDE thermometers and endoscopes which come in contact with the body fluids. Class III devices include those which come in contact with the body fluids such as that of pacemakers and heart valves.



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