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Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests

FDA Law

JUNE 22, 2023

Most recently, Jeff Shuren, CDRH Director, gave a speech at the 2023 Food and Drug Law Institute (FDLI) annual conference in which he identified facilitating “availability of and access to existing and novel home-use medical technologies” as a strategic priority for 2022-2023 to advance health equity.

Manufacturing

Manufacturing Clinic IT Transportation

Remote Patient Testing Faces a Cloudy Future under VALID

FDA Law

DECEMBER 13, 2022

Although on its face the restriction applies to LDTs, collection device manufacturers could, as a consequence, effectively be precluded from continuing to market their specimen collection devices to labs offering LDTs which enable home collection unless they first obtain authorization specifically for home collection.

Telehealth

Telehealth Patients Manufacturing Transportation

Primary Care Digest

Out At Home: FDA’s Vocal Support of Home Testing but Reluctance to Clear Novel OTC Home Tests

Remote Patient Testing Faces a Cloudy Future under VALID

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