Regulatory Approval

As part of our integrated solutions, Ranfac works within FDA guidelines as well as with Global Regulatory Bodies in bringing new products, and adaptations of existing products to market. 

This includes the submission of information that provides premarket notification of intent to market a device to the FDA, also referred to as a 510(k). In providing this information, and any further information that may be requested, Ranfac works with the FDA to demonstrate the conformity of the device.

Ranfac meets or exceeds the FDA’s Quality System Requirements. We manufacture in a facility that adheres to the FDA’s current Good Manufacturing Practices, Labeling specifications, Registration and Listing, Medical Device Reporting and any other requirement of the Food, Drug and Cosmetic Act.

Dealing with the FDA is accomplished through physical and electronic document submission as well as through direct correspondence, which can allow for a healthy exchange of ideas and help move the processes along.