It is concluded that the PSS and PSS-J are substantially equivalent and suited for use in comparative cross-cultural studies.
Most devices now available reached the market through a different process, under which the F.D.A. found them to be "substantially equivalent" to those marketed before the 1976 law took effect.
In other words, a country views another country's standards to be "substantially equivalent" to its domestic standards (even if the trading country's standards are lower).
Rather, CDRH evaluates a material within the context of the technological characteristics of the device along with the intended use and determines if the device's intended use and technological characteristics (including the materials) are substantially equivalent in safety and effectiveness to a legally marketed device.
Surely this explains why Monsanto and its allies have fought the labeling of genetically modified food so vigorously since 1992, when the industry managed to persuade the Food and Drug Administration — over the objection of its own scientists — that the new crops were "substantially equivalent" to the old and so did not need to be labeled, much less regulated.
Politics not Science Set the Agenda Dan Quayle's 1992 policy announcement is premised on the notion that genetically engineered crops are "substantially equivalent" to regular crops and thus do not need to be labeled or safety tested.
These results suggest the transgenic rice and rice from MAB breeding that were compared in the current study are substantially equivalent at the molecular and biological levels.
He said that in January 2009, the company had applied for a 510K clearance — which is based on the notion that an older device is substantially equivalent to a new one — and had yet to receive it.
But when viewed in its entirety, he added, Mr. Klein's "education, training, background and experience are substantially equivalent to the certification requirements set forth in law".
"Mr. Levy's education, training, background and experience are substantially equivalent to the requirements set forth in the law," Mr. Mills wrote in a seven-page decision after meeting with the panel yesterday.
