OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Investigational Device Exemptions

OMB 0910-0078 ยท HHS/FDA.

OMB 0910-0078

This information collection supports Food and Drug Administration (FDA, the agency, us or we) investigational device exemption (IDE) program. Respondents include private sector domestic and foreign medical device sponsors or applicants, including medical device manufacturers, investigators, hospitals, and other healthcare organizations.

The latest form for Investigational Device Exemptions expires 2029-05-31 and is listed under ICR 202505-0910-011.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0910-0078_Supporting Statement A_2026.docxSupporting Statement A
0910-0078_Supporting Statement A_2026.docxSupporting Statement A
IDE Reporting (including reports for nonsignificant studies) Other-Agency Guidance
IDE Recordkeeping Other-Agency Guidance

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202505-0910-011 Extension without change of a currently approved collection 2026-02-27
202210-0910-013 Revision of a currently approved collection 2022-11-22 Approved with change
202104-0910-011 No material or nonsubstantive change to a currently approved collection 2021-05-19 Approved with change
201912-0910-007 No material or nonsubstantive change to a currently approved collection 2019-12-18 Approved without change
201912-0910-004 No material or nonsubstantive change to a currently approved collection 2019-12-16 Improperly submitted and continue
201910-0910-002 Extension without change of a currently approved collection 2019-10-07 Approved without change
201603-0910-005 Extension without change of a currently approved collection 2016-03-22 Approved without change
201301-0910-001 Extension without change of a currently approved collection 2013-01-03 Approved without change
201212-0910-011 No material or nonsubstantive change to a currently approved collection 2012-12-17 Approved without change
201212-0910-001 Extension without change of a currently approved collection 2012-12-03 Withdrawn and continue
201001-0910-010 Extension without change of a currently approved collection 2010-01-29 Approved without change
200611-0910-001 Extension without change of a currently approved collection 2006-11-15 Approved without change
200307-0910-001 Extension without change of a currently approved collection 2003-07-02 Approved without change
200007-0910-001 Extension without change of a currently approved collection 2000-07-05 Approved without change
199707-0910-001 Reinstatement without change of a previously approved collection 1997-07-18 Approved without change
199303-0910-002 Reinstatement with change of a previously approved collection 1993-03-04 Approved without change
198811-0910-002 Reinstatement with change of a previously approved collection 1988-11-07 Approved without change
198508-0910-004 Revision of a currently approved collection 1985-08-23 Approved without change
198206-0910-004 Revision of a currently approved collection 1982-06-22 Approved without change
198004-0910-007 New collection (Request for a new OMB Control Number) 1980-04-29 Approved without change

OMB Details

IDE Reporting (including reports for nonsignificant studies)

Federal Enterprise Architecture: Health - Consumer Health and Safety