OMB control number
Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations
OMB 0910-0748 · HHS/FDA.
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 is listed under ICR 202005-0910-007.
Latest Forms, Documents, and Supporting Material
| Document | Type |
|---|---|
 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 |
Information collection |
| Pediatric information in a PMA supplement |
Information collection |
| Pediatric information in a PMA amendment |
Information collection |
| Pediatric information in an original PMA or PDP |
Information collection |
All Historical Document Collections
| Reference | Filing | Received | Concluded | Action |
|---|---|---|---|---|
| 202005-0910-007 | Revision of a currently approved collection | 2020-05-28 | Approved without change | |
| 201703-0910-003 | Extension without change of a currently approved collection | 2017-03-15 | Approved without change | |
| 201401-0910-004 | New collection (Request for a new OMB Control Number) | 2014-01-14 | Approved without change | |
| 201308-0910-002 | New collection (Request for a new OMB Control Number) | 2013-08-09 | Comment filed on proposed rule | |
| 201005-0910-001 | New collection (Request for a new OMB Control Number) | 2010-05-03 | Comment filed on proposed rule |
OMB Details
Pediatric information in an original PMA or PDP
Federal Enterprise Architecture: Health - Consumer Health and Safety