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

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.

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