Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations

OMB 0910-0748

This ICR collects information from medical device manufacturers who wish to obtain market clearance for a device. Respondents must submit, as part of their premarket approval application (PMA) or product development protocol (PDP), PMA amendment, PMA supplement, or humanitarian device exemption (HDE), readily available information providing a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected pediatric patients.

The latest form for Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations expires 2023-06-30 and can be found here.

Latest Forms, Documents, and Supporting Material

Document Name
0748 Pediatric Device Use SSA 2020 REV.pdf Supporting Statement A
Pediatric uses outside approved indication Other-Agency Guidance Document
Pediatric information in an HDE
Pediatric information in a PMA supplement
Pediatric information in a PMA amendment
Pediatric information in an original PMA or PDP

All Historical Document Collections

202005-0910-007 Approved without change	Revision of a currently approved collection	2020-05-28
201703-0910-003 Approved without change	Extension without change of a currently approved collection	2017-03-15
201401-0910-004 Approved without change	New collection (Request for a new OMB Control Number)	2014-01-14
201308-0910-002 Comment filed on proposed rule	New collection (Request for a new OMB Control Number)	2013-08-09
201005-0910-001 Comment filed on proposed rule	New collection (Request for a new OMB Control Number)	2010-05-03

OMB Details

Pediatric information in an original PMA or PDP

Federal Enterprise Architecture: Health - Consumer Health and Safety