U.S. Food and Drug Administration Updates
The U.S. Food and Drug Administration (FDA) has released several important documents. On September 16, 2014, the FDA released a final guidance for abbreviated new drug applications (ANDAs), explaining a variety of specific application deficiencies that may result in the FDA refusing to receive an ANDA. The FDA has also released a draft guidance outlining reasons for refusing to receive ANDA submissions due to improper impurity limit justifications.
Another final guidance released on October 15, 2014, explains the difference between medical device recall and market withdrawal. Whereas a recall is generally due to a product defect, a withdrawal could be due to an enhancement or discontinuation of the device. The guidance provides many concise examples and definitions. The FDA advises that companies keep records of any device removal or correction for 2 years.
Furthermore, the FDA has released a document that describes the different medical device definitions, classifications and regulatory pathways in the U.S. The document provides a fictional case study to help companies understand the best medical device regulatory pathways. Other educational documents available include a case study on the device pre market approval (PMA) process and requirements, as well as a case study on the premarket notification (510(k)) device submission process.
Finally, the FDA has fully launched Sentinel, a product safety surveillance