A LETTER URGING FDA TO TAKE A REGULATORY ACTION AGAINST THE MANUFACTURERS OF RECENTLY
INTRODUCED SURGICAL STAPLING SYSTEM PRODUCTS FOR :
(1) making unsubstantiated claim(s) regarding clinical performance of the products
(2) failing to adequately disclose the risks associated with the products
(3) withholding key scientific evidence(s) in support of the novel clinical performance claims of the products that
could potentially help uncover hidden/undisclosed risks associated with the products
A LETTER ENCOURAGING EACH PERTINENT ACADEMIC ORGANIZATION TO URGE THE MANUFACTURERS OF
CURRENTLY MARKETED SURGICAL STAPLING PRODUCTS TO :
(1) promptly acknowledge the problems associated with the currently marketed surgical stapling products as
identified by the FDA in the final reclassification order in October 2021
(2) urgently initiate efforts to update and modernize their surgical stapling products currently in the market or under
development with focus on addressing the identified problems
(3) rigorously adhere to, and proactively and clearly disclose the scientific principles or bases pertaining to the
current and future surgical stapling technologies in development and marketing of their surgical stapling products
(4) diversify the stapling products to accommodate distinctiveness in the anatomical and physiological characteristics
of organs subject to stapling operation
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