Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Dear Mr. Gonzalez: As the leading trade association representing the manufacturers of medical imaging equipment and radiopharmaceuticals, the Medical Imaging & Technology Alliance (MITA) is responding to the public docket on Clarification of Radiation Control Regulations for Manufacturers of Diagnostic X-Ray Equipment. We applaud the continued work of the FDA in this area, and respectfully provide the attached comments and recommendations in support of that good work.