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[DOC File]SITE FDA INSPECTION PREPARATION CHECKLIST
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Instructions: Use page one of this document to record information provided by the FDA at the time of initial contact. The remainder of the document should be used to track the progress of the Site FDA Inspection Preparation tasks. Check each item as it is completed and record pertinent comments. When FDA calls to schedule an inspection, obtain the following information: Staff member receiving ...
fda pre submission meeting guidance

[DOCX File]FDA Forms 1571 and 3674 - Regulatory Guidance for Academic ...
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The FDA form 3674 is a document that must accompany all FDA IND initial submissions (and some types of amendments). It is a signed statement from the sponsor/investigator that they will comply with clinicaltrials.gov requirements concerning their investigation.
fda pre submission guidance pdf

[DOC File]GENERAL INSTRUCTIONS – IDE TEMPLATE
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2020-01-16 · The Pre-Sub is an opportunity to request FDA feedback prior to intended submission of a premarket submission (i.e. IDE, 510(k), PMA, HDE, De Novo request). A Pre-Sub is appropriate when FDA’s feedback is needed to guide product development and/or submission preparation. There are several other types of submissions within the Q-Sub program:
q sub guidance fda

GENERAL INFORMATION ABOUT THIS TEMPLATE
This template (the “template”) provides the Food and Drug Administration’s (FDA) current recommendations concerning what data and information should be submitted to FDA in support of a pre ...
cdrh pre submission guidance

[DOCX File]FDA Form 3514 - Duke University School of Medicine
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2018-10-04 · List any relevant previous communications with FDA about the subject device including but not limited to any marketing submissions, IDE, 513(g), and/or Q-Sub application numbers relevant to the Pre-Sub. Include submission numbers as appropriate. Include a brief summary of these previous FDA interactions and submissions, including feedback received and resolution of that feedback (or ...
pre submission cdrh

[DOC File]GUIDANCE FOR INDUSTRY
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DRAFT GUIDANCE. This guidance document is being distributed for comment purposes only. Submit comments on this draft guidance by the date provided in the Federal Register notice announcing the availability of the draft guidance. Submit comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. You should identify ...
fda electronic submission requirements

BPI Pre-EUA.EUA Interactive Review Template Generic ... - FDA
This is a template for Pre-EUA/EUA submissions and not a guidance document. It includes the information that FDA recommends be included in such submissions, as outlined in the ...
fda guidance documents for industry

Attachment E CDRH Final Guidance Cover Sheet
Accordingly, FDA is changing the name for this program from the pre-IDE program to the Pre-Submission (Pre-Sub) program. This guidance also broadens the scope of the program to include those devices regulated by the Center for Biologics Evaluation and Research (CBER), including those that are regulated as biologics under the Public Health Service (PHS) Act and require submission of an ...
fda presubmission program guidance

[DOCX File]Target Product Profile Template
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Pre-IND . IND Submission . EOP1 . EOP2A . EOP2/Pre-Phase 3 . Pre-NDA/BLA . Other (specify) Pre-IDE . IDE Submission . 510(k) or PMA . Other (specify) Target and Annotations for Target Product Profile Log; Target. Annotations; A statement that the drug is indicated in the treatment, prevention, or diagnosis of a recognized disease or condition, OR. A statement that the drug is indicated for the ...
fda pre submission meeting guidance

Guidance for Industry and FDA Staff:
The draft of this guidance document was released on September 7, 2005. For questions regarding this document contact Carol Benson, 240-276-0396 or by email at carol.benson@fda.hhs.gov . OMB control number: 0910-0598 . Expiration Date: xx/xx/xxxx. See additional PRA statement in Section VIII of this guidance . U.S. Department of Health and Human Services . Food and Drug Administration . Center ...
fda pre submission guidance pdf

Fda pre submission guidance document