Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002

OMB 0910-0510

Information from this collection will be used by FDA to implement an Inspection by Accredited Persons program that will train and accredit persons that wish to conduct inspections of eligible manufacturers of class II and class III medical devices. This action is required by MDUFMA.

The latest form for Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 expires 2022-08-31 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0510--83C memo requesting consolidation w0569.docx Justification for No Material/Nonsubstantive Change
0510_Supporting Statement_consolidation w-0569.docx Supporting Statement A
Medical Devices; Inspection by Accredited Persons Program Under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA) Instruction
Notification of the intent to use an Accredited Person Other-Guidance

All Historical Document Collections

202101-0910-004	No material or nonsubstantive change to a currently approved collection	2021-01-14
201907-0910-007 Approved without change	Extension without change of a currently approved collection	2019-07-19
201604-0910-004 Approved without change	Extension without change of a currently approved collection	2016-04-20
201301-0910-011 Approved without change	Extension without change of a currently approved collection	2013-01-31
201001-0910-005 Approved without change	Extension without change of a currently approved collection	2010-01-27
200611-0910-003 Approved without change	Extension without change of a currently approved collection	2006-11-15
200309-0910-002 Approved without change	Extension without change of a currently approved collection	2003-09-30
200304-0910-006 Approved with change	New collection (Request for a new OMB Control Number)	2003-04-30