On August 14, 2014, the U.S. Food and Drug Administration (FDA) issued Draft Guidelines on the direct de novo classification process, a means of accelerating the approval of new types of medical devices posing only low to moderate health risks. The FDA created de novo classification in 1997, but after the process failed to achieve its purpose of expediting approval, the FDA introduced an alternative de novo process called “direct” de novo.Read More...
Archive for the ‘Agency Rulemaking’ Category
Flash Digest: News in Brief
By Suyoung Jang – Edited by Ken Winterbottom
SEC approves crowdfunding of startups
Bill introduced to criminalize warrantless use of “stingrays”
Newly introduced bill forces UK ISPs to keep a record of Web browsing history for a yearRead More...
Emulsification: Uber, UberX, and Growing Pains of the Local Sharing Economy
Written by: Michelle Sohn
Edited by: Olga Slobodyanyuk
While politics and fears of disruption certainly play large roles in this regulatory drama, this comment points to a larger legal controversy at work—the increased emulsification of commercial and private uses. Although the focus of this comment is on Uber and D.C., the larger goal is to identify major regulatory tensions with the local sharing economy by examining actual and proposed municipal regulations and laws.Read More...
Flash Digest: News In Brief
By Patrick Gutierrez
6th Circuit holds TheDirty.com immune to suit for defamatory comments made on its website
FBI, NYPD create federal cybercrime task force
Employee denied unemployment benefits for violating employer’s social media policyRead More...
FCC Cancels Controversial Plan to Survey Nation’s Newsrooms
By Corey Omer – Edited by Kim Meyer
Following intense criticism, the Federal Communications Commission has reversed course on a plan to ask media owners, news directors, and reporters invasive questions about editorial judgment and journalistic practices. A field study of the survey was scheduled to begin in South Carolina this spring but, on February 28, 2014, the agency issued a two-sentence statement laying the study permanently to rest.Read More...