Medical Devices Archives - Page 3 of 3 - Customs & International Trade Law Firm

FDA Launches New Webpage to Promote Use of Symbols in Labeling of Medical Device

Today the U.S. Food and Drug Administration (FDA) launched a new webpage to assist the public understand the Use of Symbols in Labeling Final Rule. The final rule was issued by the FDA in June 2016 and became effective three months later.

FDA intends the final rule to be an attempt to “harmonize the U.S. device labeling requirements for symbols with international regulatory requirements. As the medical device industry has requested the ability to use stand-alone symbols on domestic device labeling, consistent with their current use on devices manufactured for European and other foreign markets.” This is exciting news for our clients who are Medical Device Manufacturers or Importers – as of September 2016 all medical device labeling may use stand-alone symbols!

What does the Use of Symbols in Labeling Final Rule provide for?

Permits the use of symbols in all medical device labeling without adjacent explanatory text. This means “stand-alone symbols” may be used, but only if certain requirements are met.
Stipulates the use of symbols, accompanied by adjacent explanatory text is still permitted. This means companies are not required to relabel their products, even if they meet the requirements for the use of “stand-alone symbols”.
Revises prescription device labeling regulations, now permitting to use the symbol statement “Rx only” or “℞ only” in the labeling for prescription devices.
The final rule […]

By Jennifer Diaz|2017-04-28T18:25:00-04:00April 28, 2017|Import, International Business, International Law, International Trade, Labeling, Medical Devices, U.S. Food and Drug Administration (FDA)|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.

[…]

By Jennifer Diaz|2022-07-07T12:01:38-04:00January 27, 2017|Export, FDA Issues, Import, Medical Devices, U.S. Food and Drug Administration (FDA)|4 Comments

We are excited to announce our upcoming 3 part seminar series on Importing, Exporting, and FDA Compliance! Government and private speakers will participate.

Each seminar will provide resources for new and experienced international trade
professionals including:

[…]

By Jennifer Diaz|2016-03-16T00:32:31-04:00August 24, 2015|Best Practices, Cosmetics, Cuba, Events, Export, FDA Issues, Food, Medical Devices, OWIT, U.S Department of Homeland Security (DHS), U.S. Bureau of Industry and Security (BIS), U.S. Customs and Border Protection (CBP)|0 Comments

Jennifer Diaz Opens Medical Device Seminars at FIME

Attorney Jen Diaz will be presenting the first seminar “How to Effectively Resolve Typical U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP) Issues for Medical Devices” at the FIME Show at 10:00 AM on Wednesday, August 8, 2012 at the Miami Beach Convention Center. This will be Jen’s third consecutive year teaching at FIME.

After attending this seminar, you will know how to effectively operate your business with a new understanding of how to effectively resolve the “worst case scenarios.” We will discuss how we handle everyday examples of difficult issues with both the U.S. Food and Drug Administration (FDA) and U.S. Customs and Border Protection (CBP). FDA issues include what to do if you receive a “Notice of FDA Action” stating that a medical device is adulterated or misbranded and will be refused admission into the United States, or a “Warning Letter” that could potential state you must stop producing certain medical devices because they are adulterated or misbranded. Effectively resolving CBP issues includes the appropriate response when CBP says your goods are under “detention,” will be “seized” and “forfeited” or are included in the “detention without physical examination” list and how your company can get off the list. You will also learn the appropriate response after you receive a “liquidated damages claim” up to $50,000 from CBP.

FIME brings together the worldwide medical community for the largest and most comprehensive trade show in the United States, and features medical manufacturers from all over the globe. If you can find it in a hospital, surgery […]

By Jennifer Diaz|2022-07-06T13:50:37-04:00August 2, 2012|Medical Devices, Speaking|0 Comments

Medical Devices Seminar

On August 14, 2009, Jennifer Diaz and I will speak at the annual FIME Conference taking place at the Miami Beach Convention Center, Miami Beach, Florida. The FIME Conference is one of the largest trade shows in the United Stated attended by medical device manufacturers, importers, and distributors from throughout the United States and Latin America.

The seminar topic is “How to Effectively Resolve Typical U.S. Food and Drug Administration and U.S. Customs and Border Protection Issues for Medical Devices.”

Medical devices are strictly regulated by the FDA. We will discuss how to handle everyday examples of difficult issues with he U.S. Food and Drug Administration (FDA). FDA issues include what to do if you receive a “Notice of FDA Action” or a “Warning Letter” that could potentially state you must stop producing or importing certain medical devices. FDA may allege that the device is adulterated because you do not have an approved Premarket Approval Application (PMA) to demonstrate that the device is safe and effective for the new intended uses for which you are marketing it. In addition, the FDA may allege that a device is misbranded because you have not submitted a section 510(k) premarket notification to notify the FDA of your intent to introduce the device into commercial distribution for these new intended uses. Your company may have its imported merchandise authomatically detained by the FDA because it is on the “detention without physical examination” list. Fortunately, there is a procedure to get off that list.

Effectively resolving U.S. Customs and Border Protection (CBP) issues includes appropriately responding when CBP says your […]

By Jennifer Diaz|2015-11-30T19:29:05-05:00August 6, 2009|Food, Medical Devices|0 Comments

Previous 23

Medical Devices

FDA Launches New Webpage to Promote Use of Symbols in Labeling of Medical Device

Medical Device Registration Made Easy!

3 Part Compliance Seminar Series You DON’T Want to Miss!

Jennifer Diaz Opens Medical Device Seminars at FIME

Medical Devices Seminar