Form Fda 3514
Form Fda 3514 - Department of health and human services. Cdrh premarket review submission cover sheet (form fda 3514) the cdrh premarket review submission cover sheet for the device is provided on the following. 3514 cdrh premarket review submission cover sheet. Download form fda 3514 “cdrh premarket review submission cover.
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Cdrh premarket review submission cover sheet. Form fda 3514 (1/13) author: Entries for utilization of standards.
The Device Consists Of An Instrument, An Elongated Shaft, A Single Use Loading Cartridge Containing The Staples And The Cutting Blade, And An Anvil On Which To Form The Staples.
Form fda 3514, or the cdrh premarket review submission cover sheet, is a voluntary form used to help provide basic administrative info for all types of premarket notification. Use the following instructions to download the form if. Form fda 3514 cover sheet* section j.
Cdrh Premarket Review Submission Cover Sheet\R\N\(V5.5\) Created Date:.
Form fda 3514 was revised and reformatted to improve usability and to be inclusive of the majority of medical device product submission types. Form fda 3514 (6/05) page 4 of 5 pages note: You need to choose to open estar in the default application from within the cloud application you use, you can’t just click on it, since it will open in the browser, and.
We Revised And Reformatted Form Fda 3514, ‘‘Cdrh Premarket Review Submission Cover Sheet,’’ To Improve Usability And To Be Inclusive Of Most Medical.
Submission of this information does not affect the need to submit a 2891 or 2891a device establishment registration form. The completion of this premarket submission coversheet (form fda 3514) is voluntary and will not affect any food and drug administration (fda) decision. Depending on the browser you are using, you may need to download the form to enable field fillable functionality.
Questions Clearly Articulate A Desired Outcome Including Indications For Use Or Labeled Uses (E.g., Fda Feedback Is Requested On Clinical Study Endpoints, Inclusion.
This form may be outdated.
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