What is an 801.109 exemption?

An 801.109 exemption refers specifically to certain medical devices that are deemed to be generally recognized as safe and effective. This exemption allows these devices to bypass the premarket notification requirements typically imposed by the FDA. The rationale behind this exemption is that if a device is already widely accepted and supported by scientific evidence demonstrating its safety and efficacy, it may not require the same level of regulatory scrutiny as devices that are novel or lack such established evidence. Therefore, this facilitates a more efficient pathway for these well-established devices to be available to consumers and healthcare providers, ultimately improving access while maintaining safety standards in the marketplace. This recognition aligns with the FDA's overall goal of balancing innovation and safety in medical device regulation.