MASSDEVICE ON CALL — The medical device industry has a few qualms with the FDA’s latest proposal to add a layer of ethical review to clinical studies conducted overseas.
Medtech industry lobbying group AdvaMed commended the FDA and generally lauded the agency’s efforts to promote principals of "Good Clinical Practice" in international clinical trials, but warned that certain of the FDA’s proposals may butt heads with rules governing medical information in other countries.
AdvaMed requested that the FDA delay any finalization of overseas trials rules until "a harmonized, international medical device and IVD GCP guideline has been established and adopted," according to a response the organization submitted to the FDA.
"The development of a harmonized international medical device GCP guideline and standardized medical device definitions will help ensure that the rule, once finalized, can be implemented without major hurdles for FDA and industry," according to the letter. "It will also help to ensure that the final rule is not viewed by sovereign nations outside the US as FDA unilaterally imposing FDA GCP standards on international device regulators and the international clinical community."
Medtech titan Boston Scientific(NYSE:BSX) issued some similar concerns, echoing the call for international collaboration and support for the FDA’s recommendations.
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