FDA Law Blog

OCTOBER 10, 2023

In the case of 510(k) Implants indicated for use in pediatric patients, FDA recommends consulting two other guidance documents: Pediatrics Guidance and Extrapolation Guidance. We suggest consulting the draft guidance for a few representative examples of situations in which FDA may recommend animal testing.

Manufacturing 45

Manufacturing Engineering Clinic Patients 45

New South Family Medicine and MedSpa

NOVEMBER 24, 2022

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Family Medicine 40

Family Medicine DO Family Families 40

New South Family Medicine and MedSpa

SEPTEMBER 17, 2019

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Referral 40

Referral DO Family Medicine Primary Care 40