MITA STRESSES IMPORTANCE OF TRANSPARENCY AND STAKEHOLDER INVOLVEMENT IN 510(K) CHANGES

07.30.10

Washington, D.C. – The Medical Imaging & Technology Alliance (MITA) submitted a letter to the Center for Devices and Radiological Health on July 27 stressing that it is essential for the FDA to allow the public at least 60 days to thoroughly evaluate and respond to proposed changes to the 510(k) process. MITA also encouraged the agency to take at least 60 days to consider public comments before formulating final rules and regulations, which could greatly impact the medical device industry. Furthermore, MITA urged the FDA to develop a methodology for implementation of changes that is clearly communicated to stakeholders. MITA submitted the letter along with the Medical Device Manufacturers Association, the California Healthcare Institute and LifeScience Alley.

Click here to read the letter.

###



  • Access to Virtual Colonoscopy

    In line with American Cancer Society guidelines, H.R. 5461 would give Medicare patients access to CT colonography, often referred to as “virtual colonoscopy.” Access to virtual colonoscopy has been shown to increase colorectal cancer screening rates. Learn More


  • Further Enhancing Radiation Therapy

    A new industry-wide initiative to develop and implement additional patient protection features for radiation therapy equipment will help ensure that cancer patients receive their treatments as intended. Learn More


  • CT Radiation Dose Check Initiative

    As part of its ongoing commitment to ensuring safe, appropriate and effective medical imaging, MITA and CT manufacturers are spearheading the effort to include new, more expansive radiation dose safeguards on CT technology. Learn More