Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
This guidance describes how to compile and submit readily available pediatric use information for medical devices in premarket submissions (PMAs, HDEs, PDPs) as required by Section 515A of the FD&C Act. It applies to submissions made on or after April 10, 2014, and covers pediatric patients aged 21 years or younger.
Recommended Actions
- Create a dedicated “515A Pediatric Device Use Information” section in the submission
- Conduct thorough literature search using acceptable public sources to gather pediatric use information
- Document search methodology and criteria used for source selection
- Present information in tabular format including:
- Indication for use
- Pediatric incidence/prevalence
- Affected subpopulations
- Device components applicable to pediatric use
- Data sources
- Include narrative summary of disease/condition natural history in pediatric populations
- Ensure no proprietary or confidential information is included in pediatric use section
- For supplements, provide any new pediatric information or reference previous submission
- Consider whether special considerations apply for older adolescents (18-21 years)
- Consult FDA review division if planning to pursue specific pediatric indications, as additional data may be needed
Key Considerations
Labelling
- Information about pediatric use should be included in a separate section titled “515A Pediatric Device Use Information”
- Should include description of device uses and estimates of affected pediatric patients
- May need warnings or contraindications for pediatric use if evidence suggests potential harm
Other considerations
- Must include readily available information about pediatric subpopulations affected by the condition the device treats
- Pediatric subpopulations defined as: Neonates (0-28 days), Infants (29 days-2 years), Children (2-12 years), Adolescents (12-21 years)
- Information should come from public domain sources like peer-reviewed literature, government statistics, clinical databases
- Should include population estimates and demographic data
- Internal marketing data, sales records, and unpublished data are not acceptable sources
- Information will be used for annual Congressional reports and identifying unmet pediatric device needs
Relevant Guidances
- Premarket Assessment of Medical Devices for Pediatric Use
- Pediatric X-Ray Imaging Device Premarket Submissions: Design, Testing, and Labeling Considerations
- Leveraging Existing Clinical Data for Pediatric Medical Device Indications
Original guidance
- Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A
- HTML / PDF
- Issue date: 2014-05-01
- Last changed date: 2024-04-08
- Status: FINAL
- Official FDA topics: Medical Devices, Premarket, Pediatric Product Development, Biologics
- ReguVirta summary file ID: 3092baee8c72f2704c8dc388a38f5b74
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