FDA Now Accepting Electronic Submission of Laboratory Analyses, Plans to Automate Reviews
The Food and Drug Administration will now accept electronic versions of private laboratory reports, said CBP in a CSMS message. Electronic submission is preferred, though the FDA will still accept hard copies. The FDA intends to automate its analytical reports review processes, said the CSMS message. Once that's accomplished, FDA will be able to process private laboratory analytical reports submitted via electronic means in less time than is needed to process private laboratory analytical reports submitted in hard copy forms, it said. To avoid potential delays, private laboratory analytical reports should be submitted electronically, said CBP.
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Importers of products subject to detention without physical examination often submit laboratory analysis as testimony to overcome apparent violations, the message said. These laboratory analyses are typically provided in the form of third-party commercial laboratory analytical reports to show compliance with the Federal Food, Drug, and Cosmetic Act and with current FDA regulations.
The reports should be submitted to FDA Districts as per established District contact points. Some Districts have set up special email accounts for the purpose of accepting private laboratory analytical reports and other testimony in the Detention and Hearing process. Absent any other instructions from the District handling the entry, submissions of testimony should be routed to the contact point(s) listed in the specific Notice of FDA Action referencing the detention of the entry/line. The FDA's Import Trade Auxiliary Communication System (ITACS) isn't acceptable means of submitting private laboratory analytical reports, the message said. If and when future functionality allows for the submission of private laboratory analytical reports through ITACS, the importing community will be notified.