OMB control number

Premarket Notification Submission 510(k), Subpart E

OMB 0910-0120 · HHS/FDA.

OMB 0910-0120

This ICR collects information from persons who intend to market a medical device. Based on the information provided in the premarket notification (510(k)) submission, FDA determines whether a new device provides reasonable assurance of the safety and effectiveness of the device through substantial equivalence to a legally marketed device and whether the device can, therefore, be allowed to enter the U.S. market. Because the review of 510(k) submissions confirms that the new device is as safe and as effective as legally marketed predicate devices, potentially unsafe and/or ineffective devices, including those with fraudulent claims, are prevented from entering the U.S. market.

The latest form for Premarket Notification Submission 510(k), Subpart E expires 2029-09-30 and is listed under ICR 202508-0910-002.

View the official OMB control history on Reginfo.gov.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
Document	Type
Form FDA 4078 IVD electronic Submission Template and Resource (eSTAR)	Form and Instruction
Form FDA 4062 electronic Submission Template and Resource (eSTAR)	Form and Instruction
Form FDA 3514 CDRH Premarket Review Submission Cover Sheet	Form and Instruction
Form FDA 3881 Indications for Use	Form
0910-0120_Supporting Statement A_2026.docx	Supporting Statement A
Premarket Notification Submissions	Form and Instruction
Premarket Notification Submissions	Form and Instruction
Premarket Notification Submissions	Form and Instruction
Premarket Notification Submissions	Form and Instruction
Premarket Notification Submissions	Form and Instruction
Premarket Notification Submissions	Form and Instruction
Premarket Notification Submissions	Form
Premarket Notification Submissions	Form
Premarket Notification Submissions	Other-Guidance; Recognition and Withdrawal of Voluntary Consensu
Use of Public Human Genetic Variant Databases to Support Clinical Validity for Genetic and Genomic-Based In Vitro Diagnostics	Other-Guidance; Use of Public Human Genetic Variant Databases to

All Historical Document Collections

Historical document collections
Reference	Filing	Received	Action
202508-0910-002	Extension without change of a currently approved collection	2026-07-30
202308-0910-018	No material or nonsubstantive change to a currently approved collection	2023-08-28	Approved without change
202306-0910-007	Revision of a currently approved collection	2023-06-29	Approved without change
202109-0910-003	No material or nonsubstantive change to a currently approved collection	2021-09-10	Approved without change
202004-0910-002	Revision of a currently approved collection	2020-05-12	Approved without change
201912-0910-003	No material or nonsubstantive change to a currently approved collection	2019-12-16	Approved without change
201703-0910-017	Extension without change of a currently approved collection	2017-04-12	Approved without change
201603-0910-013	No material or nonsubstantive change to a currently approved collection	2016-03-25	Approved without change
201601-0910-004	No material or nonsubstantive change to a currently approved collection	2016-01-12	Withdrawn and continue
201504-0910-008	No material or nonsubstantive change to a currently approved collection	2015-05-01	Withdrawn and continue
201501-0910-015	No material or nonsubstantive change to a currently approved collection	2015-01-26	Approved without change
201409-0910-014	No material or nonsubstantive change to a currently approved collection	2014-10-27	Approved with change
201311-0910-009	Extension without change of a currently approved collection	2013-11-22	Approved without change
201311-0910-003	No material or nonsubstantive change to a currently approved collection	2013-11-12	Approved without change
201212-0910-005	No material or nonsubstantive change to a currently approved collection	2012-12-12	Approved without change
201008-0910-006	Revision of a currently approved collection	2010-08-17	Approved without change
200705-0910-004	Extension without change of a currently approved collection	2007-05-25	Approved without change
200403-0910-003	Extension without change of a currently approved collection	2004-03-19	Approved with change
200107-0910-004	Extension without change of a currently approved collection	2001-07-17	Approved without change
199809-0910-001	Reinstatement without change of a previously approved collection	1998-09-01	Approved without change
199302-0910-008	No material or nonsubstantive change to a currently approved collection	1993-02-24	Approved with change
199110-0910-003	Reinstatement with change of a previously approved collection	1991-10-17	Approved without change
198901-0910-006	Extension without change of a currently approved collection	1989-01-04	Approved without change
198803-0910-002	Reinstatement with change of a previously approved collection	1988-03-07	Approved without change
198610-0910-008	Revision of a currently approved collection	1986-10-23	Approved without change
198503-0910-005	Reinstatement with change of a previously approved collection	1985-03-15	Approved without change
198408-0910-008	Reinstatement with change of a previously approved collection	1984-08-06	Approved without change
198304-0910-002	Revision of a currently approved collection	1983-04-25	Approved without change
198101-0910-005	New collection (Request for a new OMB Control Number)	1981-01-28	Approved without change

OMB Details

Premarket Notification Submissions

Federal Enterprise Architecture: Health - Consumer Health and Safety

Information collection instruments
Form	Name	Electronic access	Type
Form FDA 3881	Indications for Use	Fillable Fileable	Form
Form		www.fda.gov/regulatory-information/search-fda-guidance-documents/transition-plan-medical-devices-fall-within-enforcement-policies-issued-during-coronavirus-disease	Other
Form		www.fda.gov/regulatory-information/search-fda-guidance-documents/refuse-accept-policy-510ks?utm_source=chatgpt.com	Other
Form		www.fda.gov/regulatory-information/search-fda-guidance-documents/recognition-and-withdrawal-voluntary-consensus-standards	Other
Form FDA 3514	CDRH Premarket Review Submission Cover Sheet	Fillable Fileable	Form and instruction
Form FDA 4078	IVD electronic Submission Template and Resource (eSTAR)	Fillable Fileable Signable	Form and instruction
Form FDA 4062	electronic Submission Template and Resource (eSTAR)	Fillable Fileable Signable	Form and instruction

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