Aug 20, 2019

The convergence of medical device cybersecurity requirements in Australia, Canada and the USA

Common medical device cybersecurity approaches from US, Canadian and Australian regulators
Jan 5, 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 5, 2011

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

The US Food and Drug Administration (FDA) has proposed (Docket No. FDA–2010–N–0447) new rules targeting...
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 2, 2010

US FDA 510(k) Regulatory Process Update

Important changes are affecting the US FDA’s 510(k) process; namely the Transparency Initiative and the issuance of the 21 Draft Proposals which are now open for Public Comment.
Dec 2, 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 and 13, 2009 from 8am to 5pm each day to discuss the increasing challenges that social media and the internet have presented to product regulation. The hearing will be at the National Transportation Safety Board Conference Center in Washington, D.C. In addition to the public meeting, the FDA will also accept comments (electronic and hard copy) until February 28, 2010.
May 8, 2009

US FDA may get large increase in funding

Today the Wall Street Journal published an article noting that President Obama has requested an additional $300,000,000 in funding for the US FDA, from $2.06 billion to $2.35 billion. That's a 14% increase. If the funding is approved by Congress, the agency will likely hire more inspectors which will lead to more frequent visits from the FDA to medical device manufacturers.
May 1, 2009

US FDA announces new website

The Food and Drug Administration has said that it plans to launch a redesigned website, presumably in 2009. This should be good news for users of the site. Hopefully, guidance documents and other relevant information will be easier to find, and databases will be easier to use. Keep your fingers crossed.
Apr 9, 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