Home » Presubmission Draft Guidance Due Soon, Industry Best Practice Paves Way for Now
Presubmission Draft Guidance Due Soon, Industry Best Practice Paves Way for Now
A new draft guidance outlining expectations for presubmission meetings with the U.S. Food and Drug Administration (FDA) is expected in the next few months, regulators said during a March 5 Regulatory Affairs Professionals Society meeting. The draft will include information on pre-510(k), premarket approval, humanitarian device exemption and investigational device exemption meetings and submissions.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor
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