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International Medical Device Regulatory Monitor
October 2009 | Vol. 17 No. 10
Makers of IVDs for HPV Should Meet With US FDA if Using Foreign Data
Makers of in vitro diagnostics (IVD) for human papillomavirus (HPV) should request a pre-submission meeting with the U.S. Food and Drug Administration (FDA) if they plan to use data from clinical trials in other countries to support their premarket approval (PMA) application, a new draft guidance says. Includes the full text of US FDA Draft Guidance on In Vitro Diagnostic Devices.
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