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Medical Device Registration Made Easy!

This article 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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By |2021-11-09T13:54:48-05:00January 27, 2017|Export, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|4 Comments
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CBP Launches New E-Commerce and Small Business Branch … Just in Time for the Holiday Shopping Season

With Thanksgiving in the rear view mirror and the Christmas holiday season kicking into high gear, now is the time to think of Pre-Compliance especially with the grave risks associated with shopping online and not knowing your supplier. As Small Business Saturday and Cyber Monday commercial activity spikes, CBP is, in specific connection with online sales, warns consumers and merchants alike to be on the lookout for holiday shopping scams and/or criminal trade practices. Red flags to watch for in this regard include offers designed to induce the purchase of counterfeit and/or unsafe goods, prices that are too good to be true, e-commerce sites that lack legitimate phone numbers and/or addresses, and sellers who lack good customer feedback.

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By |2021-11-09T14:11:38-05:00December 1, 2016|Best Practices, Import, U.S. Customs and Border Protection (CBP)|Comments Off on CBP Launches New E-Commerce and Small Business Branch … Just in Time for the Holiday Shopping Season
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FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming

Do you manufacture, process, pack or hold human food? If so, you need to keep up with the Food Safety Modernization Act (FSMA). The FDA has proposed a new rule issued under the FSMA that is part of a broader effort to prevent food borne illness and ensure the safety of imported and domestically produced foods. Here's a recap of the proposed rule and your chance to comment to the FDA. You have until May 16, 2013 to submit your comments to the FDA on the proposed rule.

By |2021-11-10T14:26:25-05:00January 30, 2013|Food, FSMA, Import, U.S. Food and Drug Administration (FDA)|Comments Off on FDA’s Busy Implementing FSMA – Significant New Food Safety Rules are Coming
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FDA Administrative Detention of Food… What can you do?

Just a few weeks ago, FDA investigators ordered an administrative detention of a Maine company's cold-smoked salmon product, a ready-to-eat food, during an inspection. Once the food was detained, Mill Stream Corp. agreed to voluntarily destroy the cold-smoked salmon, under FDA supervision, after inspectors found Listeria monocytogenes within the company's facility and on its processing equipment.

By |2019-10-22T01:41:17-04:00March 9, 2012|Food, FSMA|1 Comment
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Seafood Fraud

In 2010, Americans consumed almost 6 billions pounds of seafood. The U.S. Food and Drug Administration (FDA) is responsible for ensuring that the nation's food supply, including seafood, is safe, wholesome, and properly labeled. That is a tough task considering 80% of the seafood we eat is imported from countries all over the world. Unfortunately, the reality is that seafood fraud is common. Moreover, it can have not only economic, but food safety, consequences.

By |2011-03-09T12:18:08-05:00March 9, 2011|Food, U.S. Food and Drug Administration (FDA)|Comments Off on Seafood Fraud
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I am Not Worried That My Food Is “Safe”, Are You?

The United States Congress is considering legislation to make the food we eat, especially imported food, "safe and secure". In my opinion, even if our food needs protecting, the proposed legislation only adds to the current Federal bureaucracy. The U.S. Food and Drug Administration already has a comprehensive regulatory procedure to stop, examine, and refuse imported food which it considers adulterated or misbranded, or otherwise not fit for human consumption. The current FDA system is working very well, and the only achievement of the proposed legislation will be to increase the price of food.

By |2009-11-10T09:55:01-05:00November 10, 2009|Food, Import, U.S. Food and Drug Administration (FDA)|2 Comments
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