Registration

Keep Your Eyes Peeled For the Single Export Licensing System!

Currently the U.S. government has three different agencies that have been given the authority to issue export licenses. Those three agencies are: the Departments of Commerce, State, and the Treasury. In 2009, President Obama ordered an interagency review of the current export control system. The review found that the current system was “overly complicated, contained too many redundancies, and, in trying to protect too much, diminished the ability to focus their efforts on the most critical national security priorities”. The review also found that many companies had to apply for multiple export licenses with each of the departments. Due to the findings of the review, the Administration created the Export Control Reform initiative to help establish a single export licensing system.

“The goal of the (ECR) initiative is to create a Single Licensing Agency (SLA), which would act as a ‘one stop shop’ for businesses seeking export license and for the US government to coordinate review of license applications.” The ultimate goal of this new licensing process would be to make the process predictable, timely, and transparent.

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By |2022-07-07T12:02:32-04:00February 6, 2017|Export|0 Comments

Medical Device Registration Made Easy!

This article is a continuation of: “What Do Dental Floss, Bedpans, and Pacemakers Have in Common?”, and discusses the three types of medical device classifications and how to register and list those devices with the FDA.

FDA’s classes of medical devices:

The Food and Drug Administration (FDA) has established classifications for approximately 1,700 different generic types of medical devices.”

The device classification is broken up into three regulatory classes (Class I-III), which is “based on the level of control necessary to assure the safety and effectiveness of the device”. To determine the device classification, the FDA looks at “the intended use of the device and also the indications for use“. According to the FDA’s Guidance on Device Regulation, the intended use of a device “means the general purpose of the device or its function, and encompasses the indications for use”. Indications for use is “a general description of the disease or condition the device will diagnose, treat, prevent, cure, or mitigate, including a description of the patient population for which the device is intended”. (21 C.F.R. §814.20(b)(3)(i)). The class for which your medical device would belong to, determines the type of pre-market submission or application that is required for FDA clearance to sell the medical device in the United States.

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