Medical devices are regulated by government agencies and the FDA has a major role in the safety and effectiveness of the medical devices introduced in the market. This is so because the design complexity also risks the challenge of ensuring that new testing methods are employed to regulate medical devices to the set FDA standards. Risk-based testing is thus proving to be a significant concept in this regard as it provides a systematic strategy to prevent all types of risks in the entire life cycle of a product. The focus of this paper is to review different testing methodologies using risk approaches commonly practised in the medical device industry to address the requirements of the FDA. Risk-based testing not only helps to simplify the procedure of meeting the requirements of legislation but also aims at a more rational use of resources and enhanced decisions on creating and maintaining medical devices. To compile this research on risk-based testing about FDA standards for medical devices, the current literature and practices in the field have been reviewed.