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Democrats insist that the state laws must be at least substantially equivalent to the federal standards.
In a report a fortnight ago, it claimed the treaty was substantially equivalent to the rejected constitution.
PrePex was cleared by the F.D.A. because it was judged "substantially equivalent" to the SmartKlamp, Ms. Fuerst said.
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".
If a state could show that its insurance laws were "at least substantially equivalent" to the new federal standards, the state law would remain in effect, and state officials could enforce the patient protections of state 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.
Similar(45)
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.
The company said that the payments are "substantially equivalent" to those it would pay to an unaffiliated company, and that the Commerce board believes the arrangement with InterArch has been "an important factor in the success of the Commerce brand".
So lawmakers provided the quick review process for any new product deemed "substantially equivalent" to something already on the market.
The shorter approval pathway requires companies to show a product is "substantially equivalent" to one already on the market and typically does not require human testing.
For devices that pose a lower level of risk to patients, a manufacturer need only show that a new product is substantially equivalent to one already on the market.
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Justyna Jupowicz-Kozak
CEO of Professional Science Editing for Scientists @ prosciediting.com