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Medical device reporting (MDR) is the procedure for the Food and Drug Administration to get significant medical device adverse events information from manufacturers, importers and user facilities, so these issues can be detected and corrected quickly, and the same lot of that product may be recalled.
In 1971, Bose Corporation sued Consumer Reports (CR) for libel after CR reported in a review that the sound from the system it reviewed "tended to wander about the room". [75] The case eventually reached the United States Supreme Court , which affirmed in Bose Corp. v. Consumers Union of United States, Inc. that CR 's statement was made without ...
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The US Food and Drug Administration requires that developers of medical device follow a system of design controls.A key part of this system is design review, defined in 21CFR820.3 section (h) as "a documented, comprehensive, systematic examination of the design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet these requirements, and to ...
The Court held, on a 6–3 vote, in favor of Consumers Union, the publisher of Consumer Reports magazine, ruling that proof of "actual malice" was necessary in product disparagement cases raising First Amendment issues, as set out by the case of New York Times Co. v. Sullivan (1964). The Court ruled that the First Circuit Court of Appeals had ...
The typical front-loading commercial washing machine also differs from consumer models in its discharge of spent wash and rinse water. While the consumer models pump used washer water out, allowing the waste drainage pipe to be located above the floor level, front-loading commercial machines generally use only gravity to expel used water. A ...
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