SS Innovations Announces Filing of Pre-Submission Application to the Center for Devices and Radiological Health (CDRH) of the United States Food and Drug Administration
SS Innovations received acknowledgement of this pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.
- SS Innovations received acknowledgement of this pre submission filing (#Q240119) from the Center for Devices and Radiological Health (CDRH) on January 17, 2024.
- The CDRH is responsible for regulating firms who manufacture, repackage, relabel, or import medical devices sold in the United States.
- In addition, CDRH regulates medical and non-medical radiation-emitting electronic products such as lasers, x-ray systems and ultrasound equipment.
- SS Innovations Founder, Chairman and Chief Executive Officer, Dr. Sudhir Srivastava, commented, “The filing of our pre-submission application with the CDRH is a pivotal step for SS Innovations, and provides an opportunity for us to gather feedback in an interactive meeting with the FDA prior to our planned 510(k) premarket submission for the SSi Mantra™ Surgical Robotic System.