IND & IDE Support

IDE Templates and Forms

For more information and guidance, see “IDE Development.” [prettyfilelink size=”External Link” src=”http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm” newwindow=”true”]FDA Forms[/prettyfilelink][prettyfilelink size=”66 kB” src=”/wp-content/uploads/ITHS_-InitialIDE_-StudyProtocolTemplate.dotx” type=”doc”]Study Protocol for a medical device study[/prettyfilelink][prettyfilelink size=”32 kB” src=”/wp-content/uploads/ITHS_InitialIDESubmissionTemplate.dotx” type=”doc”]IDE Submission[/prettyfilelink][prettyfilelink size=”22 kB” src=”/wp-content/uploads/ITHS_InitialIDECoverLetterTemplate.dotx” type=”doc”]IDE Cover Letter[/prettyfilelink][prettyfilelink size=”110 kB” src=”/wp-content/uploads/All-IDE-Templates.zip” type=”zip”]All IDE Templates[/prettyfilelink]

IND Templates and Forms

For more information and guidance, see “IND Development.”

Initial Submission

[prettyfilelink size=”External Link” src=”http://www.fda.gov/AboutFDA/ReportsManualsForms/Forms/default.htm” newwindow=”true”]FDA Forms[/prettyfilelink][prettyfilelink size=”22 kB” src=”/wp-content/uploads/ITHS_Template_Request_for_IND_Waiver.dotx” type=”doc”]Request for IND Waiver [/prettyfilelink][prettyfilelink size=”26 kB” src=”/wp-content/uploads/ITHS_Template_Request_for_Pre-IND_Meeting.dotx” type=”doc”]Request for Pre-IND Meeting[/prettyfilelink][prettyfilelink size=”17 kB” src=”/wp-content/uploads/ITHS_Template_Pre-IND_Briefing_Packet.dotx” type=”doc”]Pre-IND Briefing Packet[/prettyfilelink][prettyfilelink size=”82 kB” src=”/wp-content/uploads/Protocol_template.dotx” type=”doc”]Study Protocol for a drug study[/prettyfilelink][prettyfilelink size=”42 kB” src=”/wp-content/uploads/ITHSTemplate_Initial_IND_Submission.docx” type=”doc”]IND Submission[/prettyfilelink][prettyfilelink size=”22 kB” src=”/wp-content/uploads/ITHSTemplate_Initial_IND_Submission_Cover_letter.dotx” type=”doc”]IND Cover Letter[/prettyfilelink]

Protocol Amendments

[prettyfilelink size=”23 kB” src=”/wp-content/uploads/ITHSTemplate_Protocol_Amendment_New_Investigator_Cover_letter.dotx” type=”doc”]IND Protocol Amendment Cover Letter – New Investigator[/prettyfilelink][prettyfilelink size=”23 kB” src=”/wp-content/uploads/ITHSTemplate_Protocol_Amendment_New_-Protocol_or_Change_-in_Protocol_Cover_letter.dotx” type=”doc”]IND Protocol Amendment Cover Letter – New Protocol or Change in Protocol[/prettyfilelink][prettyfilelink size=”897 kB” src=”http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM074728.pdf” type=”pdf” newwindow=”true”]FDA Form 1572[/prettyfilelink][prettyfilelink size=”105 kB” src=”http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf” type=”pdf”]FDA Form 1572 FAQs – final guidance[/prettyfilelink]

Safety Reports

[prettyfilelink size=”External Link” src=”http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048334.pdf” type=”pdf” newwindow=”true”]IND Safety Report – MedWatch Form FDA 3500A[/prettyfilelink][prettyfilelink size=”23 kB” src=”/wp-content/uploads/ITHSTemplate_IND_Safety_Report_Cover_letter.dotx” type=”doc”]IND Safety Report Cover Letter[/prettyfilelink]

Annual Reports

[prettyfilelink size=”41 kB” src=”/wp-content/uploads/ITHSTemplate_IND_Annual_Report.dotx” type=”doc”]IND Annual Report[/prettyfilelink][prettyfilelink size=”22 kB” src=”/wp-content/uploads/ITHSTemplate_IND_Annual_Report_Cover_letter.dotx” type=”doc”]IND Annual Report Cover Letter[/prettyfilelink]