What is required for a manufacturer to sell a medical device?

To sell a medical device, a manufacturer must provide evidence that the device is both effective and safe. This requirement is established to ensure that any medical device brought to market meets the standards set by regulatory authorities, such as the Food and Drug Administration (FDA) in the United States. This process typically involves rigorous testing and data collection to demonstrate that the device works as intended and does not pose unreasonable risks to patients or users.

Evidence of effectiveness and safety is essential because this protects public health and ensures that healthcare providers and patients can trust the technology being used. Manufacturers must often submit a premarket notification [510(k)] or a premarket approval (PMA) application, depending on the classification of the device. In both cases, the submission must include comprehensive data to support the claims of safety and effectiveness.

Other options do not accurately capture the primary requirement for medical device sales. While state authorities may have their own regulations, the core requirement is rooted in safety and effectiveness as mandated by federal regulations, making it insufficient as a standalone prerequisite. The concept of a minimum number of sales and peer reviews are not formal requirements for approval to sell a medical device, although they might play roles in market success and acceptance. Therefore, the emphasis on providing evidence of effectiveness and