OMB.report

Federal forms, ICRs, and supporting documents

OMB control number

Reclassification Petitions for Medical Devices

OMB 0910-0138 ยท HHS/FDA.

OMB 0910-0138

This information collection helps to implement section 515 (21 U.S.C. 360e) of the Federal Food, Drug, and Cosmetic Act, with regard to the reclassification of medical devices. Section 515 provides, among other things, that, upon petition, a manufacturer may request that FDA reclassify a medical device. Accordingly, we have established reclassification procedures consistent with statutory requirements that set forth format and content elements.

The latest form for Reclassification Petitions for Medical Devices expires 2028-07-31 and is listed under ICR 202406-0910-001.

Latest Forms, Documents, and Supporting Material

Latest forms, documents, and information collections
DocumentType
0138--ReclassPetitions--SSA for ROCIS 11-04-24.docxSupporting Statement A
Reclassification Petitions for Medical Devices Information collection

All Historical Document Collections

Historical document collections
ReferenceFilingReceivedConcludedAction
202406-0910-001 Extension without change of a currently approved collection 2024-12-20
202201-0910-002 Extension without change of a currently approved collection 2022-01-26 Approved without change
201812-0910-009 Revision of a currently approved collection 2019-01-30 Approved with change
201806-0910-010 Extension without change of a currently approved collection 2018-08-20 Approved without change
201505-0910-006 Extension without change of a currently approved collection 2015-06-16 Approved without change
201207-0910-010 No material or nonsubstantive change to a currently approved collection 2012-07-26 Approved without change
201203-0910-009 Extension without change of a currently approved collection 2012-03-29 Approved with change
200903-0910-005 Extension without change of a currently approved collection 2009-03-27 Approved without change
200512-0910-004 Extension without change of a currently approved collection 2005-12-22 Approved without change
200211-0910-001 Extension without change of a currently approved collection 2002-11-08 Approved without change
199912-0910-001 Extension without change of a currently approved collection 1999-12-07 Approved without change
199809-0910-015 No material or nonsubstantive change to a currently approved collection 1998-09-13 Approved without change
199612-0910-001 Reinstatement without change of a previously approved collection 1996-12-11 Approved without change
199103-0910-001 Reinstatement with change of a previously approved collection 1991-03-29 Approved without change
198905-0910-003 No material or nonsubstantive change to a currently approved collection 1989-05-02 Approved with change
198705-0910-003 Extension without change of a currently approved collection 1987-05-05 Approved without change
198511-0910-005 Reinstatement with change of a previously approved collection 1985-11-13 Approved without change
198408-0910-006 Reinstatement with change of a previously approved collection 1984-08-06 Approved without change
198401-0910-007 No material or nonsubstantive change to a currently approved collection 1984-01-04 Approved with change
198212-0910-003 Revision of a currently approved collection 1982-12-27 Approved without change
198110-0910-002 New collection (Request for a new OMB Control Number) 1981-10-30 Approved without change