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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:
predicate device
English translation:
the legally marketed device(s) to which equivalence is drawn
English to English translations [PRO] Medical - Medical: Pharmaceuticals / care solution of contact lens
English term or phrase:predicate device
Context: The following is a comparison of the chemical composition of the alternate formulation with the predicate device formulation.
Note: can somebody tell me in simple English what "predicate device" means?
Explanation: A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s).
Sounds complicated. Feeling dizzy, I had better go to bed, leaving it to tomorrow morning for clarification and proper Chinese words. Thank you all!
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Answers
6 mins confidence: peer agreement (net): +1
the legally marketed device(s) to which equivalence is drawn
Explanation: A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), or a device which has been reclassified from Class III to Class II or I, a device which has been found to be substantially equivalent to such a device through the 510(k) process, or one established through Evaluation of Automatic Class III Definition. The legally marketed device(s) to which equivalence is drawn is known as the "predicate" device(s).
A. a Class I or II device already legally on the market; or
B. "preamendment" Class III device (one that has been in commercial distribution since before May 28, 1996) for which the FDA has not called for PMA applications.
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A predicate device can be either:
* a similar device of any Class that was on the market before May 28, 1976;
* a similar device legally marketed after May 28, 1976 that has been placed in Class I or Class II; or
* any similar device that has already been found by the FDA to be substantially equivalent to a device described above. http://www.geocities.com/Baja/Cliffs/1326/xagt021200.htm
The translation workplace 
Software comparison tool
