Amy J. Reed Collaborative Files Multiple FDA Petitions
On the Record
The Amy J. Reed Collaborative for Medical Device Safety recently mounted a multifront push to strengthen FDA oversight, transparency and patient safety in medical device regulation. Professors David A. Simon (left) and Hooman Noorchashm (right), its co-directors, filed a petition requesting a publicly accessible database of all medical device labels; a petition requesting a Class 1 recall of Intuitive Surgical’s da Vinci 5 robotic surgical systems; and a petition demanding the FDA rescind or amend its clearance of the da Vinci SP Surgical System for nipple-sparing mastectomy, arguing the FDA acted without awaiting results from an ongoing clinical trial.
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