predicate device
English translation: the legally marketed device(s) to which equivalence is drawn
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| 13:42 Apr 8, 2004 |
| English language (monolingual) [PRO] Medical - Medical: Pharmaceuticals / care solution of contact lens | |||||||
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|  Selected response from: elenus Local time: 22:30 | ||||||
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| Discussion entries: 4 | |
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Answers
6 mins confidence: 
peer agreement (net): +1
peer agreement (net): +1the 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). see link http://www.fda.gov/cdrh/devadvice/314.html -------------------------------------------------- Note added at 7 mins (2004-04-08 13:50:08 GMT) -------------------------------------------------- see link: http://www.premierinc.com/frames/index.jsp?pagelocation=/all... -------------------------------------------------- Note added at 8 mins (2004-04-08 13:50:51 GMT) -------------------------------------------------- please confidence \"4\" |
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7 mins confidence:
predicate device Explanation: http://www.fda.gov/cdrh/devadvice/31432.html Hope this helps :) -------------------------------------------------- Note added at 9 mins (2004-04-08 13:51:54 GMT) -------------------------------------------------- Agh! I know what you mean about \"plain English\", because I, for one, cannot understand such mumbo-jumbo at this time of morning... Sorry! :( ~*T.*~ |
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9 mins confidence: peer agreement (net): +3
peer agreement (net): +3explanation Explanation: "predicate device" which is either: 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. -------------------------------------------------- Note added at 17 mins (2004-04-08 13:59:52 GMT) -------------------------------------------------- here is more on what class 1 and 2 device mean http://www.fda.gov/CDRH/DEVADVICE/3132.html#class_1 -------------------------------------------------- Note added at 22 mins (2004-04-08 14:04:43 GMT) -------------------------------------------------- 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 Reference: http://www.shannontechnologies.com/fda.html |
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