More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...

The draft guidance addresses concerns that pulse oximeters are less accurate for people with dark skin tones. Experts raised ...

Over 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) within the deadline set by federal regulations, finds an analysis of recent data ...

Diagnos Inc. (“DIAGNOS” or the “Corporation”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of ...

Nearly 10% of postmarket device safety reports in MAUDE were submitted over 6 months after the safety event occurred.

Objective To describe the extent of late adverse event reporting by manufacturers to the US Food and Drug Administration’s (FDA) Manufacturer And User Facility Device Experience (MAUDE) database as ...

THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...

The founding director of the FDA’s Office of Biotechnology writes that, with FDA approval of medications ultimately vested ...

The "FDA Inspection" training has been added to ResearchAndMarkets.com's offering. This seminar provides the fundamentals and the ground rules on how to prepare for and survive an FDA inspection no ...

For years, medtech firms around the globe (and certainly European companies) introduced their products in Europe, which requires obtaining a CE ...

The National Association of Boards of Pharmacy (NABP) plays an important role in the state licensing of prescription medical device manufacturers ...