May ,15 2019

La directive définitive sur le programme préliminaire Q-Sub FDA traite de la cybersécurité des dispositifs médicaux

Jan ,05 2011

Sharfstein Out at FDA

The FDA’s second-in-command Joshua Sharfstein is stepping down as principal deputy commissioner to become Maryland’s secretary of health and mental hygiene, according to
Jan ,05 2011

FDA Proposes Recordkeeping Requirements for Third-party 510(k) Reviewers

The US Food and Drug Administration (FDA) has proposed (Docket
Dec ,10 2010

Mexican Market Entry Just Got Easier

Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms. The Mexican Health Author
Dec ,02 2010

US FDA 510(k) Regulatory Process Update

Important changes are affecting the US FDA’s 510(k) process; namely
Dec ,02 2010

FDA issues report on proposed objectives for CDRH's 510(k) program

A newly released FDA report has been made available for public comment until October 4, 2010.
Sep ,23 2009

FDA Hosts Public Hearing to Address the Internet and Social Media and how they Relate to Product Regulation

The FDA is holding a public hearing on November 12
May ,08 2009

US FDA may get large increase in funding

Today the Wall Street Journal published an article noting that
May ,01 2009

US FDA announces new website

The Food and Drug Administration has said that it plans
Apr ,09 2009

US FDA issues notice on preamendment Class III devices

The Food and Drug Administration (FDA) just posted a notice in the April 9, 2009 Federal Register notifying manufacturers of 25 types of Class III medical devices that their products will be subject t