OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Premarket Approval of Medical Devices

OMB 0910-0231 ยท HHS/FDA.

OMB 0910-0231

This information collection supports implementation of statutory requirements that govern premarket approval of medical devices. Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Respondents to the information collection are PMA applicants, or persons who own the rights, or otherwise have authorized access, to the data and other information to be submitted in support of FDA approval. This person may be an individual, partnership, corporation, association, scientific or academic establishment, government agency or organizational unit, or other legal entity.

The latest form for Premarket Approval of Medical Devices expires 2026-05-31 and is listed under ICR 202211-0910-010.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0231_Supporting Statement_2026.docxSupporting Statement A
Premarket Approval of Medical Devices: Reporting Other-Agency Guidance - Providing Information about Pediatric Us
Certificate of Compliance w/42 CFR part 11 Information collection
Premarket Approval of Medical Devices: Maintenance of Records Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202602-0910-004 Reinstatement without change of a previously approved collection 2026-07-14
202211-0910-010 Revision of a currently approved collection 2023-03-30 Approved without change
202001-0910-010 Extension without change of a currently approved collection 2020-03-20 Approved without change
201912-0910-005 No material or nonsubstantive change to a currently approved collection 2019-12-16 Approved without change
201701-0910-017 Extension without change of a currently approved collection 2017-01-31 Approved without change
201512-0910-003 No material or nonsubstantive change to a currently approved collection 2016-01-12 Approved without change
201504-0910-009 No material or nonsubstantive change to a currently approved collection 2015-05-04 Withdrawn and continue
201501-0910-014 No material or nonsubstantive change to a currently approved collection 2015-01-26 Approved without change
201409-0910-013 No material or nonsubstantive change to a currently approved collection 2014-10-17 Approved with change
201311-0910-010 Extension without change of a currently approved collection 2013-11-22 Approved without change
201311-0910-004 No material or nonsubstantive change to a currently approved collection 2013-11-12 Approved without change
201212-0910-006 No material or nonsubstantive change to a currently approved collection 2012-12-12 Approved without change
201010-0910-003 Extension without change of a currently approved collection 2010-10-15 Approved without change
200709-0910-005 Extension without change of a currently approved collection 2007-09-27 Approved without change
200407-0910-009 Extension without change of a currently approved collection 2004-07-14 Approved without change
200105-0910-003 Extension without change of a currently approved collection 2001-05-18 Approved without change
199905-0910-003 Reinstatement without change of a previously approved collection 1999-05-06 Approved without change
199902-0910-001 Extension without change of a currently approved collection 1999-02-03 Withdrawn and continue
199710-0910-004 Reinstatement without change of a previously approved collection 1997-10-24 Approved without change
199309-0910-001 Revision of a currently approved collection 1993-09-03 Approved without change
199004-0910-004 Reinstatement with change of a previously approved collection 1990-04-13 Approved without change
198906-0910-010 No material or nonsubstantive change to a currently approved collection 1989-06-13 Approved with change
198607-0910-001 New collection (Request for a new OMB Control Number) 1986-07-23 Approved without change

OMB Details

Premarket Approval of Medical Devices: Reporting

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
FormNameElectronic accessType
Form FDA 3674Certificate of ComplianceFillable FileableForm and instruction

Review document collections for all forms, instructions, and supporting documents - including paper/printable forms.