Compliance Group

Medical devices, unlike prescription drugs, are reviewed by the United States (US) Food and Drug Administration (FDA) under one of two regulatory standards – Premarket approval (PMA), which requires clinical testing and inspections, or the 510(k) process, which does not. The second standard is intended for devices with a low or no risk of failure, as determined by the FDA. The medical device must be similar to a previously marketed device (predicate device). Introduction The FDA categorizes medical devices into one of three categories based on the level of control required to ensure the safety and effectiveness of the device and the level of risk the device poses to patients. Class I devices pose the least risk and are subject to minimal regulation — examples: tongue depressors, bandages, crutches, stethoscopes, and bandages. Class II devices pose a moderate risk and may be cleared through the 510(k) premarket notification process, which allows them to be marketed if they are substant...

With the emerging technologies, medical devices are a cost factor despite their long-term cost-saving modes and improved patient safety measures. However, medical device manufacturing companies should take precautions to avoid compliance regulations issues.. Let’s look at the most common  medical device regulatory compliance  problems faced by quality leaders in the 21st century. Read More .