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PRE-IDE

English translation: إجراءات ماقبل استخراج ترخيص استثنائي لاستخدام جهاز طبي غير مجرب سابقا

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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
Entered by: Nadia Ayoub
Options:
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19:23 Aug 24, 2008
Arabic to English translations [PRO]
Medical - Medical: Pharmaceuticals
Arabic term or phrase: PRE-IDE
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
Dina Ali
Egypt
Local time: 13:58
إجراءات ماقبل استخراج ترخيص استثنائي لاستخدام جهاز طبي غير مجرب سابقا
Explanation:
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.
Selected response from:

Nadia Ayoub
Egypt
Local time: 13:58
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer

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Summary of answers provided
5 +3إجراءات ماقبل استخراج ترخيص استثنائي لاستخدام جهاز طبي غير مجرب سابقا
Nadia Ayoub
4سابق لإستثاء جهاز فحص
Mohsin Alabdali


Discussion entries: 2





  

Answers


52 mins   confidence: Answerer confidence 5/5 peer agreement (net): +3
إجراءات ماقبل استخراج ترخيص استثنائي لاستخدام جهاز طبي غير مجرب سابقا


Explanation:
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.



    Reference: http://rc.kfshrc.edu.sa/ORA/Forms/ORA%205.1.5.5%20%20%20Glos...
Nadia Ayoub
Egypt
Local time: 13:58
Native speaker of: Arabic
PRO pts in category: 20
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Fathy Shehatto: You are right.
25 mins
  -> Thanks a lot Fathy :)

agree  a1interpreter: http://www.fda.gov/cdrh/ode/d99-1.pdf
3 hrs
  -> Thanks a lot A1 :)

agree  amrhonest
2 days12 hrs
  -> Many thanks Amr :)
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4 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
سابق لإستثاء جهاز فحص


Explanation:
ID = Investigational Device = جهاز فحص

سواء كان الفحص يتم في مختبر أو في المنزل، مثل جهاز فحص مستوى السكر في الدم

Mohsin Alabdali
Saudi Arabia
Local time: 14:58
Native speaker of: Native in ArabicArabic
PRO pts in category: 3
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Changes made by editors
Sep 7, 2008 - Changes made by Nadia Ayoub:
Created KOG entryKudoZ term » KOG term


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