Katrina’s Blog™

The announcement on March 5th (in a staff letter which was shared on Twitter) that Scott Gottlieb, Commissioner of the FDA, would resign at the end of the month has created considerable speculation in the press. Along with questions about why (Dr. Gottlieb gave family...

Not all class I or II medical devices are required to undergo a premarket notification process with the FDA. Additionally, certain preamendment unclassified devices are considered to be sufficiently well understood that they, too, do not require premarket...

Humanitarian Device ExemptionA rare disease is defined in the Orphan Drug Act (ODA) of 1984 as a disease or condition that affects fewer than 200,000 people in the United. Because so few patients are affected, it can be difficult to gather enough clinical evidence for...

De NovoThe DeNovo Classification process has yet to be established in the regulations, though it was added to the FD&C Act in 1997 and further updated in subsequent amendments. A proposed rule for the DeNovo process was published in early December 2018 and will be...