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picture1_Pre Sub Instruction Sheet 2020 | Sample Submission


picture2_Pre Sub Instruction Sheet 2020 | Sample Submission picture3_Pre Sub Instruction Sheet 2020 | Sample Submission

 125x       Filetype DOC       File size 0.07 MB       Source: medschool.duke.edu


File: Pre Sub Instruction Sheet 2020 | Sample Submission
GENERAL INSTRUCTIONS – FDA PRE-SUBMISSION (PRE-SUB) IS THE PRE-SUB THE CORRECT MECHANISM WITHIN THE Q-SUB PROGRAM FOR REQUESTING FDA FEEDBACK FOR MY PROJECT? The Pre-Sub is an opportunity to request ...

icon picture DOC Filetype Word DOC | Posted on 06 Jul 2022 | 2 years ago

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...General instructions fda pre submission sub is the correct mechanism within q program for requesting feedback my project an opportunity to request prior intended of a premarket i e ide k pma hde de novo appropriate when s needed guide product development and or preparation there are several other types submissions issue sir on proposed approach address issues conveyed in hold letter marking study risk determinations determination whether planned medical device clinical significant sr non nsr exempt from regulations informational meeting share information with without expectation may also be used regarding design which results not support future this case you should clearly note your cover that additional uses https www gov downloads medicaldevices deviceregulationandguidance guida ncedocuments ucm pdf where do send these current addresses but please confirm website devices regulated by center radiological health cdrh u food drug administration document control wo g new hampshire avenue...
								

							

						
	
												
				
					
					
					
			
					
				
				
		
	

	
		





	

	
				

						

						
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										Category:  Standard Format / Word Format 
										
Posted on: 06 Jul 2022 | 2 years ago
										
										
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																								Sample Submission,
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Filetype: DOC
										
File size: 0.07 MB
										
Views: 125x
										
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										Wan learn
											

												Wan learn