Did you know FDA has issued 1,569 enforcement actions against medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.
Register today to to hear directly from DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally market a medical device and best practices for avoiding and responding to enforcement actions.
Why Should I Register for this Webinar?
The FDA is actively enforcing its laws and regulations against non-compliant importers of medical devices. In FY21 alone the FDA has issued 53 warning letters against medical devices companies. Manufacturers, repackagers, relabelers, importers, and others engaged in the production or sale of medical devices must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, import alerts, seizures, voluntary recalls, injunctions, and criminal prosecution.
In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.
Warning Letters issued in FY21:
- Of the 53 warning letters issued to medical device companies in FY2021, 50% of these warning letters were issued against firms that marketed their medical devices as devices that treat or mitigate Covid-19. FDA found these devices (including “KN95 Face Mask” and “3-ply Surgical Mask Disposable Face Mask”) to be “Unapproved Drugs, Misbranded, and/or Adulterated Products Related to Coronavirus Disease 2019 (COVID-19)”.
- In FY21, FDA warning letters have been issued against firms for offering medical devices for sale in the United States without marketing approval, clearance, or authorization from the FDA as well as poor current Good Manufacturing Practices (cGMPs).
- Interestingly enough 40 of the 52 warning letters were against U.S. and Chinese companies.
Recalled Medical Devices in 2020 and 2021:
- In FY21, FDA has recalled a total of 2161 medical devices, including the recall of 132 Class I devices, 1986 Class II devices, and 43 Class III devices have been recalled in FY21!
- In FY20 a total of 3042 medical devices were recalled.
- There are a total of 304 firms currently performing medical device recalls. Don’t be one of them!
In this webinar, you will receive an overview of FDA regulations and requirements for importing medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device. The objective of the webinar is to teach participants how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.
Manufacturers, importers, distributors, and others engaged in the production or sale of medical devices are encouraged to attend either live on August 25, 2021 at 12:00 PM, or on demand thereafter. Register Here!