Glossary entry (derived from question below)
English term or phrase:
predicate device
English answer:
the legally marketed device(s) to which equivalence is drawn
Added to glossary by
elenus
Apr 8, 2004 13:42
20 yrs ago
37 viewers *
English term
Accurate -- Reliable -- Fast
Native in: Chinese 
Works in: English to Chinese, Chinese to English, German to Chinese, and 3 more.
predicate device
English
Medical
Medical: Pharmaceuticals
care solution of contact lens
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?
Note: can somebody tell me in simple English what "predicate device" means?
Responses
Responses
+1
6 mins
Selected
the legally marketed device(s) to which equivalence is drawn
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
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Note added at 7 mins (2004-04-08 13:50:08 GMT)
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see link: http://www.premierinc.com/frames/index.jsp?pagelocation=/all...
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Note added at 8 mins (2004-04-08 13:50:51 GMT)
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please confidence \"4\"
see link http://www.fda.gov/cdrh/devadvice/314.html
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Note added at 7 mins (2004-04-08 13:50:08 GMT)
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see link: http://www.premierinc.com/frames/index.jsp?pagelocation=/all...
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Note added at 8 mins (2004-04-08 13:50:51 GMT)
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please confidence \"4\"
4 KudoZ points awarded for this answer.
Comment: "Thank you all for perfect information. "
7 mins
María Teresa Taylor Oliver
Panama
Panama
Panama
Synesthete with a flair for tasty words!
Native in: Spanish (Variants: US, Guatemalan, Salvadoran, Latin American, Colombian, Costa Rican, Panamanian, Nicaraguan, Mexican, Peruvian, Venezuelan, Cuban, Honduran, Argentine) 
Works in: Spanish to English, English to Spanish
Related KudoZ points
:
4
predicate device
http://www.fda.gov/cdrh/devadvice/31432.html
Hope this helps :)
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Note added at 9 mins (2004-04-08 13:51:54 GMT)
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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.*~
Hope this helps :)
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Note added at 9 mins (2004-04-08 13:51:54 GMT)
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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.*~
+3
9 mins
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.
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Note added at 17 mins (2004-04-08 13:59:52 GMT)
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here is more on what class 1 and 2 device mean
http://www.fda.gov/CDRH/DEVADVICE/3132.html#class_1
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Note added at 22 mins (2004-04-08 14:04:43 GMT)
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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
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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Note added at 17 mins (2004-04-08 13:59:52 GMT)
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here is more on what class 1 and 2 device mean
http://www.fda.gov/CDRH/DEVADVICE/3132.html#class_1
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Note added at 22 mins (2004-04-08 14:04:43 GMT)
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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
Reference:
Peer comment(s):
| agree |
Vicky Papaprodromou
9 mins
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thank you:)
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| agree |
NancyLynn
52 mins
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thank you :)
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| agree |
Mario Marcolin
1 hr
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thanks Mario
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+1
29 mins
device that was legally marketed in the US prior to May 28, 1976
This is the definition which apprears in this website:
www.fda.gov/cdrh/manual/510kprt1.html
Another website explains that May 28, 1976 was the date the device amendments were made to the Food, Drug and Cosmetic Act.
Reference: www.fdamaz.com/Dealing with FDA.pdf
Another website adds that it is a device that was legally marketed prior to May 28, 1976 "and has not been significantly change/modified since then, and for which a regulation requiring a PMA application has not been published by the FDA or which has been reclassified from class 3 to class 2".
Reference: www.ivthome.com/free/se/510k.htm
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Note added at 36 mins (2004-04-08 14:18:46 GMT)
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I am adding the end of the long definition which appears in the last reference: \"or which itself has been found to be substantially equivalent through the 510k process, after May 28, 1976.\"
www.fda.gov/cdrh/manual/510kprt1.html
Another website explains that May 28, 1976 was the date the device amendments were made to the Food, Drug and Cosmetic Act.
Reference: www.fdamaz.com/Dealing with FDA.pdf
Another website adds that it is a device that was legally marketed prior to May 28, 1976 "and has not been significantly change/modified since then, and for which a regulation requiring a PMA application has not been published by the FDA or which has been reclassified from class 3 to class 2".
Reference: www.ivthome.com/free/se/510k.htm
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Note added at 36 mins (2004-04-08 14:18:46 GMT)
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I am adding the end of the long definition which appears in the last reference: \"or which itself has been found to be substantially equivalent through the 510k process, after May 28, 1976.\"
+1
11 hrs
chica nueva
Native in English
&
English
http://youtube/iraVWQu3Zf8
Native in: English (Variants: British, New Zealand)
Works in: Chinese to English
predicate = to base (something) on or upon facts, conditions, etc
What the words mean??
predicate [chiefly US] = to base (something) on or upon facts, conditions, etc (Collins Concise English Dictionary)
=> adj = base, original, former??
device = ?? (no, sorry, I don't know why it would be called device, unless it means 'clause' or 'regulatory device = rule')
predicate [chiefly US] = to base (something) on or upon facts, conditions, etc (Collins Concise English Dictionary)
=> adj = base, original, former??
device = ?? (no, sorry, I don't know why it would be called device, unless it means 'clause' or 'regulatory device = rule')
Peer comment(s):
| agree |
German Hernandez
: BAsicalyu, would mean, original formula because in that context, it is being compared to an alternate formulation. So, the sentence means, in plain english a comparison among the original formulation and an alternate formulation.
14 hrs
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