To allow for devices with a predetermined change control plan to be marketed without submitting a supplemental application or premarket notification if the changes to such devices are consistent with such plan.

Bill 117 hr 8299, also known as the "Change Control Plan Act," aims to streamline the process for marketing medical devices that have a predetermined change control plan in place. Under this bill, manufacturers of medical devices would not be required to submit a supplemental application or premarket notification if the changes made to the devices are consistent with the predetermined plan.

The purpose of this legislation is to reduce regulatory burdens on manufacturers and expedite the approval process for medical devices that have already been approved by the Food and Drug Administration (FDA). By allowing devices with a predetermined change control plan to be marketed without additional paperwork, the bill seeks to encourage innovation in the medical device industry and ensure that safe and effective devices reach the market in a timely manner.

Supporters of the bill argue that it will help to streamline the regulatory process and promote efficiency in the approval of medical devices. However, critics have raised concerns about the potential impact on patient safety and the FDA's ability to monitor changes to devices once they are on the market. Overall, Bill 117 hr 8299 represents an effort to balance the need for regulatory oversight with the goal of promoting innovation in the medical device industry. It will be important for lawmakers to carefully consider the potential implications of this legislation on patient safety and the effectiveness of the FDA's regulatory oversight.