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predicate device

English translation: the legally marketed device(s) to which equivalence is drawn

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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
Entered by: elenus
Options:
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- Include in personal glossary

13:42 Apr 8, 2004
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?
Jianming Sun
Local time: 18:43
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).

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\"
Selected response from:

elenus
Local time: 13:43
Grading comment
Thank you all for perfect information.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3explanation
Kornelia Longoria
4 +1device that was legally marketed in the US prior to May 28, 1976Pnina
3 +1predicate = to base (something) on or upon facts, conditions, etc
chica nueva
3predicate device
María Teresa Taylor Oliver
1 +1the legally marketed device(s) to which equivalence is drawn
elenus


Discussion entries: 4





  

Answers


6 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5 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).

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\"

elenus
Local time: 13:43
Native speaker of: Native in RomanianRomanian
PRO pts in category: 16
Grading comment
Thank you all for perfect information.

Peer comments on this answer (and responses from the answerer)
agree  Ray Luo
54 mins
  -> Thanks Ray :)
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7 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
predicate device


Explanation:
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.*~

María Teresa Taylor Oliver
Panama
Local time: 05:43
Native speaker of: Native in SpanishSpanish
PRO pts in category: 4
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9 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
explanation


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


    Reference: http://www.shannontechnologies.com/fda.html
Kornelia Longoria
United States
Local time: 05:43
Specializes in field
Native speaker of: Native in PolishPolish

Peer comments on this answer (and responses from the answerer)
agree  Vicky Papaprodromou
9 mins
  -> thank you:)

agree  NancyLynn
52 mins
  -> thank you :)

agree  Mario Marcolin
1 hr
  -> thanks Mario
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29 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
device that was legally marketed in the US prior to May 28, 1976


Explanation:
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.\"

Pnina
Israel
Local time: 13:43
Native speaker of: Native in HebrewHebrew

Peer comments on this answer (and responses from the answerer)
agree  NancyLynn
32 mins
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11 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
predicate = to base (something) on or upon facts, conditions, etc


Explanation:
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')



chica nueva
Local time: 22:43
Native speaker of: English

Peer comments on this answer (and responses from the answerer)
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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