Apr 8, 2004 23:47
20 yrs ago
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 to Chinese
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 what "predicate device" means?
Note: can somebody tell me what "predicate device" means?
Proposed translations
(Chinese)
| 4 +2 | 已上市之旧产品 |
Chinoise
|
| 5 | 进行实质等效比较的产品 |
clearwater
|
| 4 | for reference in english |
Xiedong Lei
|
Proposed translations
+2
15 mins
Selected
已上市之旧产品
已上市之旧产品
3 KudoZ points awarded for this answer.
Comment: "Thank you all! It is 已上市之旧产品 but is
a device that:
Was legally marketed in the U.S. prior to May 28, 1976 , and has not been significantly changed since then. Thanks for the good English reference as well. "
27 mins
进行实质等效比较的产品
进行实质等效比较的产品
http://www.zmdcc.com/fda/fda_04.asp
http://www.zmdcc.com/fda/fda_04.asp
Peer comment(s):
| neutral |
Wenjer Leuschel (X)
: 做为进行实质等效比较的旧产品
15 mins
|
4 hrs
Xiedong Lei
China
China
Native in Chinese
Specializes in field
China
SDL User -- 23 years’ medical background
Native in: Chinese
Works in: English to Chinese, Chinese to English
Related KudoZ points
:
12
for reference in english
A predicate device is a device that:
Was legally marketed in the U.S. prior to May 28, 1976 (preamendment; “grand-fathered” devices), and:
Has not been significantly changed/
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 III to Class II; or
Which itself has been found to be substantially equivalent through the 510(k) process, after May 28, 1976.
The term predicate device only applies to devices in categories subject to 510(k) review, and not devices requiring premarket approval (PMA), since the basis of the PMA is not a comparison of one device to another (preexisting device) as it is in a 510(k).
Was legally marketed in the U.S. prior to May 28, 1976 (preamendment; “grand-fathered” devices), and:
Has not been significantly changed/
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 III to Class II; or
Which itself has been found to be substantially equivalent through the 510(k) process, after May 28, 1976.
The term predicate device only applies to devices in categories subject to 510(k) review, and not devices requiring premarket approval (PMA), since the basis of the PMA is not a comparison of one device to another (preexisting device) as it is in a 510(k).
Reference:
Discussion