Bill 119 HR 88, also known as the Non-Invasive Diagnostic Device Regulation Act, aims to make changes to the Federal Food, Drug, and Cosmetic Act in order to exempt certain non-invasive diagnostic devices from regulation as medical devices. The bill seeks to streamline the regulatory process for these types of devices, which are used for diagnostic purposes without penetrating the skin or body cavities.
The main purpose of this bill is to promote innovation and access to non-invasive diagnostic devices by reducing regulatory burdens on manufacturers. By exempting these devices from certain regulations, the bill aims to encourage the development of new technologies that can improve healthcare outcomes and patient care.
In addition to exempting non-invasive diagnostic devices from regulation, the bill also includes provisions for other purposes related to the regulation of medical devices. These provisions are aimed at ensuring the safety and effectiveness of medical devices while also promoting innovation and access to new technologies.
Overall, Bill 119 HR 88 is focused on promoting innovation in the field of non-invasive diagnostic devices and improving access to these technologies for healthcare providers and patients. The bill aims to strike a balance between ensuring the safety and effectiveness of medical devices and reducing regulatory burdens that may hinder innovation in this important area of healthcare.