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  • 1.  FDA Age Range Definitions

    Posted 17-Aug-2020 14:08
    Edited by Ed Panek 17-Aug-2020 14:11
    FDA has age ranges defined for Neonate, Infant, Children, and adolescents. I inferred that an adult is =>21 y/o but it's not clearly defined nor are elderly or senior citizens. Is that correct?

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    Edward Panek
    VP, QA/RA
    Blue Spark Technologies
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  • 2.  RE: FDA Age Range Definitions

    Posted 18-Aug-2020 07:49
    The upper range for a pediatric population is <17 years under PREA and Pediatric Study Plan regulations. However, the actual age to include in clinical trials may be different under different therapeutic guidance and local laws.

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    Glen Park PharmD
    Executive Director, Regulatory Affairs and Quality Assurance
    Jersey City NJ
    United States
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    Original Message


  • 3.  RE: FDA Age Range Definitions

    Posted 18-Aug-2020 09:54
    FDA does define geriatric age as being 65 and older (21 CFR 201.57) as it pertains to labeling requirements. In some guidances, for example the E11 guidance, pediatric is defined as through 18 but that can vary depending on region.

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    Holly Bilinski, MS, RAC
    Ann Arbor, MI
    United States
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    Original Message


  • 4.  RE: FDA Age Range Definitions

    Posted 18-Aug-2020 10:18

    Hello Ed,

     FDA has slightly different pediatric age ranges for drugs (adolescents: ages 12 to less than 17 years) and medical devices (adolescents: ages 12 through 21 (up to but not including the 22nd birthday)). FDA has not defined age ranges for the adult and geriatric populations due to the different considerations for the wide variety of medical devices and diagnostics but suggests to specify age ranges based on relevant disease characteristics.

    FDA's guidance "Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" may be of interest to you.



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    Patricia Taige RAC
    Regulatory Affairs Manager
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    Original Message


  • 5.  RE: FDA Age Range Definitions

    Posted 18-Aug-2020 10:26
    Thank you all for the responses. Appreciated!

    Ed

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    Edward Panek
    VP, QA/RA
    Blue Spark Technologies
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


  • 6.  RE: FDA Age Range Definitions

    Posted 19-Aug-2020 14:00
    FDA published a 2014 guidance, "Providing Information about Pediatric Uses of Medical Devices", that clarifies how FDA defines the pediatric patients and pediatric subpopulations.
    • Neonates: from birth through the first 28 days of life;
    • Infants: 29 days of age to less than two years of age;
    • Children: Two years of age to less than 12 years of age; and
    • Adolescents: 12 years of age through 21 years of age (up to, but not including, the twentysecond
      birthday).
    I've not seen any clarification on geriatric patients

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    David Geraghty
    Director QA & RA
    Redmond WA
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    Original Message


  • 7.  RE: FDA Age Range Definitions

    Posted 09-Nov-2020 15:09
    Does EU MDD/MDR have a similar grouping?

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    Edward Panek
    VP, QA/RA
    Med Device
    Research into Neural Nets - https://www.twitch.tv/edosani
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    Original Message


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