Japan Tobacco and Swedish Match on “Substantial Equivalence”: Support for the 510(k) Program as a Model

Japan Tobacco and Swedish Match, among others, state their support for the 510(k) medical device provision as a model for substantial equivalence in the tobacco program, they state:

 The 510(k) Program Provides A Clear Model For An Effective Pre-Market Review Program

“If FDA determines that the proposed device is “substantially equivalent” to a legally marketed predicate device, FDA will issue a letter “clearing” the device for marketing. In implementing these provisions, FDA noted that it “should not require a premarket notification for every change…since too many…changes are made on a regular basis.”FDA concluded that changes with little to no impact on health should be exempt from the substantial equivalence filing requirement, and issued regulations establishing that only those modifications that could “significantly affect the safety or effectiveness of the device” or that constitute a “major change or modification” in the device’s intended use require a submission under Section 510(k).”

      .. the FDA’s device modification decision-tree itself has been enormously successful for both the medical device industry and FDA, by striking a balance between the pronouncement of broad, subjective principles that are difficult to follow and detailed enumeration of specific standards, which the guidance notes would “be an impossible task.”

    “The principles and circumstances that led FDA to promulgate and implement the 510(k) program are directly relevant to the issues faced by FDA as it seeks to implement Sec905(j) of the Tobacco Control Act.”

Complete comments:  Substantial Equivlance Comments

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