www.fdanews.com/articles/145603-presubmission-draft-guidance-due-soon-industry-best-practice-paves-way-for-now
Presubmission Draft Guidance Due Soon, Industry Best Practice Paves Way for Now
April 13, 2012
A new draft guidance outlining expectations for presubmission meetings with the U.S. Food and Drug Administration (FDA) is expected in the next few months, regulators said during a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