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AdvaMed comenta na edição do Preemption a respeito dos dispositivos médicos

por Astrid Fiano, DOTmed News Writer | June 17, 2008

The Committee heard testimony from patients and health industry experts on the pros and cons of the preemption issue.

The House Committee on Oversight and Government Reform also held hearings on preemption in May, including testimony from Randall Lutter, Ph.D., Deputy Commissioner for Policy, Food and Drug Administration, and other legal and health experts. The FDA said in its testimony that it is "concerned that state product liability lawsuits that challenge FDA's careful determination of safety, efficacy and appropriate labeling can have detrimental effects to public health in a number of ways, including limiting patient and doctor choices, decreased patient access to beneficial products, and increased confusion over warnings or statements that can deter the use of beneficial medical products."

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For more information, see the following sources:

http://oversight.house.gov/story.asp?ID=1943

http://www.fda.gov/ola/2008/stateliability051408.html

http://judiciary.senate.gov/hearing.cfm?id=3404

http://www.advamed.org/MemberPortal/About/NewsRoom/NewsReleases/
pr-06-11-08-preemptn-statement-cw.htm

For previous DOTmed News coverage, go to:
https://www.dotmed.com/news/story/4956/

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