The FDA has allowed a substantial amount of late reports and undated reports into its Manufacturer and User Facility Device ...

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

MethodSense says it is helping pulse oximeter manufacturers with FDA draft guidance to enhance accuracy across diverse skin ...

Panel raises concern over regulatory roadblocks affecting medical devices sector: Gireesh Babu, New Delhi Thursday, March 13, 2025, 08:00 Hrs [IST] The delays and lack of transpar ...

As of late February, there were 147 medical device recall events and 20 of them, or 13.6%, were Class I, according to a Modern Healthcare report.

The company does not expect the warning letter to materially impact its manufacturing capacity, sales or ability to seek ...

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 ...

Diagnos Inc. (“ DIAGNOS ” or the “ Corporation ”) (TSX Venture: ADK, OTCQB: DGNOF, FWB: 4D4A), a pioneer in early detection of critical health issues through the use of its FLAIRE platform based on ...

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 ...

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 ...