MITA URGES INSTITUTE OF MEDICINE TO CONSULT WITH MEDICAL DEVICE INDUSTRY ON 510(K) CHANGES

Washington, D.C. – In a letter submitted July 27, the Medical Imaging & Technology Alliance (MITA) urged the Institute of Medicine to open the lines of communication and broadly consult with members of the medical device industry when assessing and making recommendations on the 510(k) system. Changes to the 510(k) process have the potential to impact the medical device industry in both positive and negative ways, by either fostering innovation through transparency or by stifling product development through burdensome regulations. MITA submitted the letter to the members of the Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process with 14 other industry associations.

Click here to read the letter.

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