Regulatory Outlook
Mar 22, 2012
       Nancy Singer         Mark Lagunovich Successfully implementing and documenting...
Feb 22, 2012
Medical device companies face an expanding set of legal and regulatory requirements to address risks and concerns around product safety. Scrutiny from the...
Jun 14, 2011
With the emergence of interactive, real-time Internet communication and social networks, medical device companies now have access to new methods for engaging...
May 13, 2011
Product recalls are challenging for any manufacturer, but when it comes to medical devices and life sciences, speed is of the essence. Any delay in a product...
May 04, 2011
By requiring mandatory CE marking, the Medical Device Directive 93/42/EEC has greatly contributed to the harmonization of regulatory requirements in the 27 EU...
Feb 23, 2011
Risk evaluation and mitigation strategy (REMS) is a regulatory technique implemented by FDA to ensure that the benefits of a specific drug outweigh its...
Oct 20, 2010
DeRisio FDA launched the Medical Device Safety Network (MedSun) in 2002 as a supplement to mandatory and voluntary MedWatch reporting. Currently...
Oct 01, 2010
Hills Bhatt A recall is defined as a “firm’s voluntary removal or correction of a marketed product that FDA considers to be in violation...
Sep 01, 2010
Ladin Imhoff Medical device manufacturers interested in marketing their products in the United States are required to secure FDA marketing clearance...
Aug 09, 2010
Caryn Silverman Evan Smith The Medical Device Safety Act of 2009 (MDSA)—H.R. 1346—was introduced by Representatives Frank Pallone Jr. (D...