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

OMB 0910-0748

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.

OMB Details

Pediatric information in an original PMA or PDP

Federal Enterprise Architecture: Health - Consumer Health and Safety


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