Glossary entry (derived from question below)
Arabic term or phrase:
PRE-IDE
English translation:
إجراءات ماقبل استخراج ترخيص استثنائي لاستخدام جهاز طبي غير مجرب سابقا
Added to glossary by
Nadia Ayoub
Aug 24, 2008 19:23
15 yrs ago
5 viewers *
Arabic term
PRE-IDE
Arabic to English
Medical
Medical: Pharmaceuticals
What is a Pre-IDE?
*A misnomer
*A free consultative service by the review staff at the FDA
*A non binding agreement between FDA & sponsor
*Results in a well prepared submission
*Results in a shortened review time
*Results in saving research $$$
Pre-IDE Process
Protocol proposal (1)
Introduction
A clearly stated intended use
Test principles
Device description
Intended Use Statement
Should address the followings:
Qualitative or Quantitative
Testing matrix
Intended Population
Adult /Children/Age limitations
Asymptomatic--Screening
Symptomatic--Diagnosis
Already diagnosed--Monitoring
In conjunction with other diagnostics or stand alone test
*A misnomer
*A free consultative service by the review staff at the FDA
*A non binding agreement between FDA & sponsor
*Results in a well prepared submission
*Results in a shortened review time
*Results in saving research $$$
Pre-IDE Process
Protocol proposal (1)
Introduction
A clearly stated intended use
Test principles
Device description
Intended Use Statement
Should address the followings:
Qualitative or Quantitative
Testing matrix
Intended Population
Adult /Children/Age limitations
Asymptomatic--Screening
Symptomatic--Diagnosis
Already diagnosed--Monitoring
In conjunction with other diagnostics or stand alone test
Proposed translations
(English)
| 5 +3 | إجراءات ماقبل استخراج ترخيص استثنائي لاستخدام جهاز طبي غير مجرب سابقا |
Nadia Ayoub
|
| 4 | سابق لإستثاء جهاز فحص |
Mohsin Alabdali
|
Change log
Sep 7, 2008 07:26: Nadia Ayoub Created KOG entry
Proposed translations
+3
52 mins
Nadia Ayoub
Egypt
Egypt
Native in Arabic
Egypt
Never lost for words!
Native in: Arabic
Works in: English to Arabic, Arabic to English, Italian to Arabic, and 4 more.
Related KudoZ points
:
20
Selected
إجراءات ماقبل استخراج ترخيص استثنائي لاستخدام جهاز طبي غير مجرب سابقا
Pre-IDE Process
Sponsors are encouraged to contact FDA to obtain further guidance prior to the submission of an IDE application. This will be especially beneficial to new sponsors who have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for existing technologies. Early interaction with the agency should help to increase the sponsor's understanding of FDA requirements, regulations, and guidance documents, and will allow FDA personnel to familiarize themselves with the new technologies. Increased interaction between FDA and sponsors should help to speed the regulatory process and minimize delays in the development of useful devices intended for human use. The communication with FDA may take the form of a "Pre-IDE" meeting and/or a "Pre-IDE" submission.
Sponsors are encouraged to contact FDA to obtain further guidance prior to the submission of an IDE application. This will be especially beneficial to new sponsors who have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for existing technologies. Early interaction with the agency should help to increase the sponsor's understanding of FDA requirements, regulations, and guidance documents, and will allow FDA personnel to familiarize themselves with the new technologies. Increased interaction between FDA and sponsors should help to speed the regulatory process and minimize delays in the development of useful devices intended for human use. The communication with FDA may take the form of a "Pre-IDE" meeting and/or a "Pre-IDE" submission.
Peer comment(s):
| agree |
Fathy Shehatto
: You are right.
25 mins
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Thanks a lot Fathy :)
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| agree |
Sajjad Hamadani
: http://www.fda.gov/cdrh/ode/d99-1.pdf
3 hrs
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Thanks a lot A1 :)
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| agree |
amrhonest
2 days 12 hrs
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Many thanks Amr :)
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4 KudoZ points awarded for this answer.
Comment: "Selected automatically based on peer agreement."
4 hrs
سابق لإستثاء جهاز فحص
ID = Investigational Device = جهاز فحص
سواء كان الفحص يتم في مختبر أو في المنزل، مثل جهاز فحص مستوى السكر في الدم
سواء كان الفحص يتم في مختبر أو في المنزل، مثل جهاز فحص مستوى السكر في الدم
Discussion
The process has since evolved into a means for gaining feedback in several other areas, most notably for non-significant risk, exempt or post-market studies which do not require an IDE submission, but which will generate data to support an eventual marketing submission.
Pre-IDE meetings are also especially beneficial for medical device manufacturers who have not had previous contact with the FDA and whose device utilizes new technologies or involves new uses of existing technologies. This early interaction with the FDA helps clients to gain a clearer understanding of relevant medical device regulations, requirements, and guidance documents. It is provides an excellent means to obtain the FDA’s input and guidance regarding the appropriate regulatory pathway, the proper approach to refine and/or define clinical data and statistical analyses, and to answer critical questions related to clinical study design.