Testing (Hepatitis C)

At-Home Test Receives Expedited and Streamlined Review from FDA

Published in Blood Weekly, March 8th, 1999

The U.S. Food and Drug Administration (FDA) has informed Home Access Health Corp., that its pre-market approval application (PMA) for an at-home telemedicine Hepatitis C counseling and testing service will received expedited review and streamlined processing from the agency.

In a letter from FDA, the agency said Home Access Health's "Hepatitis C Check" test service was granted expedited review status because "the device may meet some specific public health needs in making available counseling and information on hepatitis C status information to a broader public."

The agency specifically mentioned the current hepatitis C "Lookback Guidance" as one of...

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Source: Blood Weekly (1999-03-08)

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