FDA Regulation

The Food and Drug Administration’s (FDA), Center  for Devices and Radiological Health (CDRH) is responsible for clearing medical imaging products including CT, fluoroscopy, mammography, x-ray, ultrasound, nuclear medicine and magnetic resonance for sale in the United States. MITA collaborates closely with the FDA on numerous initiatives from improvement of the product clearance process, to efforts to reduce patients’ exposure to medically unnecessary radiation. MITA believes that transparency is key to a smooth and efficient regulatory process and that lack of regulatory predictability is a significant barrier to product innovation.

To improve regulatory predictability, MITA believes it is important that FDA communicate, on an ongoing and frequent basis, policies and practices regarding current and proposed regulatory requirements and their underlying rationales.   This includes communicating the dates when proposed rules, guidance and other critical regulatory documents will be issued, or, if the issuance of these documents will be delayed, their expected date of issuance and reasons for the delay. As well, it is important that FDA communicate the status of product submissions to applicants on a frequent and ongoing basis.