Feb 7, 2011

Jaw Implants under FDA Scrutiny

Jaw implant manufacturers are apparently the latest segment of the medical device industry to experience the new get-tough stance by US regulators. The three major manufacturers of temporomandibula
Jun 10, 2011

Health Canada’s Surveillance Process Found Lacking

Canada’s Office of the Auditor General has found Health Canada’s medical device surveillance and inspection...
Aug 18, 2011

FDA Proposes Longer Post-Market Surveillance Requirements for Pediatric Devices

New draft guidance from the US Food and Drug Administration recommends compliance pathways for medical device manufacturers regarding
Sep 16, 2011

HC Amends Procedure for Mandatory Problem Reports

Canadian medical device market regulator Health Canada will begin requiring manufacturers and importers to send Mandatory Problem Reports (MPRs) to its Health Canada Vigilance-Medical Device Progra
Dec 19, 2011

New FDA Guidance Emphasizes Gender Differences in Clinical Studies

New draft guidance from the US Food and Drug Administration recommends improvements to medical device...
Mar 2, 2015

National US Postmarket Surveillance System Takes Further Shape

A new report commissioned by the US Food and Drug Administration recommends a seven-year, multi-step...
Mar 2, 2015

US-Überwachungssystem nach der Markteinführung nimmt Form an

Ein neuer, von der US Food and Drug Administration in Auftrag gegebener Bericht empfiehlt einen...