Providing Pediatric Use Information for Medical Device Premarket Submissions Under Section 515A

What You Need to Know? 👇

What types of medical device submissions require pediatric use information under FDA Section 515A?

Section 515A applies to PMAs, PMA supplements, HDEs, and PDPs submitted after April 10, 2014. However, 30-day manufacturing change notices are excluded as they’re not considered PMA supplements under the statutory distinction.

How does FDA define pediatric subpopulations for medical device submissions?

FDA defines four pediatric subpopulations: Neonates (birth-28 days), Infants (29 days to <2 years), Children (2 to <12 years), and Adolescents (12-21 years). These age ranges align with national statistical standards.

What constitutes “readily available information” for pediatric device use reporting?

Readily available information includes public domain data from sources like PubMed, CDC databases, peer-reviewed journals, and clinical trial registries. It excludes proprietary data, internal marketing reports, and unpublished abstracts.

Where should pediatric use information be placed in a medical device submission?

Create a separate section titled “515A Pediatric Device Use Information” in your submission. For modular PMAs, include this information in the final module containing clinical data and proposed labeling.

What data must be included about pediatric populations in device submissions?

Submissions must describe pediatric subpopulations affected by the device’s intended condition and provide estimates of affected patient numbers overall and within each subpopulation, based on population counts or statistically valid surveys.

Can pediatric use information alone establish a new pediatric indication for medical devices?

No, Section 515A information is insufficient to establish safety and effectiveness for new pediatric indications. Additional clinical data would generally be required, and FDA consultation is recommended for extrapolation strategies.

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What You Need to Do 👇

Recommended Actions

1. Create a dedicated “515A Pediatric Device Use Information” section in the submission
2. Conduct thorough literature search using acceptable public sources to gather pediatric use information
3. Document search methodology and criteria used for source selection
4. Present information in tabular format including:
   • Indication for use
   • Pediatric incidence/prevalence
   • Affected subpopulations
   • Device components applicable to pediatric use
   • Data sources
5. Include narrative summary of disease/condition natural history in pediatric populations
6. Ensure no proprietary or confidential information is included in pediatric use section
7. For supplements, provide any new pediatric information or reference previous submission
8. Consider whether special considerations apply for older adolescents (18-21 years)
9. 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

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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

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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 ID: 3092baee8c72f2704c8dc388a38f5b74