What we learned

Both medical device transition plans follow a similar structure, with some minor differences, in what is asked for from the trade community. Under the issued medical device transition plans, the entire plan follows a 180-day cycle in which by day 90 notifications of intent must be submitted to the FDA and by day 180, marketing submissions must be submitted and accepted by FDA. Please see below for a more thorough breakdown of each of the transition plans.

Devices Issued Emergency Use Authorizations (EUA)

Day 0: Advance notice of termination in Federal Register – EUAs are still active for the full 180-day transition time period

By Day 90:

• FDA recommends that manufacturers of certain life-supporting or life-sustaining devices submit to FDA a “letter of intent”, with information regarding their intention to submit a marketing submission to continue the distribution of their product. or their intention to cease distribution of their product and how they intend on doing so.  The draft guidance recommends that manufacturers of such devices include in this notification:
  • General information (e.g., contact information).
  • The EUA request number.
  • A list of all model numbers or other device identifying information.
  • Whether the manufacturer plans to submit a marketing submission.
  • If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plan to stop distribution of the device, to restore the device to a previously FDA-cleared or approved version, to provide a physical copy or electronic updated labeling, and any other efforts to address or mitigate potential risks of devices that remain distributed after the EUA termination date.
• The manufacturer should submit this information designated with the EUA number as an “EUA report.” FDA recommends that manufacturers notate the following on the cover letter of the submission: “Attention: Notification of Intent.”

By Day 180:

• Manufacturers should have a marketing submission submitted and accepted by the FDA meaning FDA has confirmed receipt of the marketing submission.  You are allowed to continue the importation and distribution of your device until the FDA issues a final action on your marketing submission.
• According to the draft guidance, marketing submissions should be considered “transition implementation plan that addresses the manufacturers’ plans for devices already distributed in the case of a positive decision or a negative decision on its marketing submission”. This marketing submission should include the following:
  • Information regarding the estimated number of devices distributed under an EUA currently in U.S. distribution.
  • A benefit-risk based plan for disposition of distributed product as detailed in the draft guidance.
  • A plan on how the manufacturer would cease distribution of their product should they receive a negative decision from the FDA.

Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency (PHE)

Day 0: A Final ruling will be issued by the FDA ending the Public Health Emergency and changing the enforcement policies, but the trade community will still have the 18o day time period to become compliant with the “new” laws and regulations.

By Day 90:

• FDA recommends that manufacturers of certain life-supporting or life-sustaining devices submit to FDA a “letter of intent”, with information regarding their intent to submit a marketing submission or not. The guidance recommends that manufacturers of such devices include in this notification,
  • General information (e.g., contact information).
  • The title of the relevant enforcement policy guidance.
  • Submission number(s) for related premarket submissions.
  • A list of all model numbers or other device identifying information.
  • Whether the manufacturer plans to submit a marketing submission.
  • If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plan to
    • discontinue distribution of the device
    • to restore the device to a previously FDA-cleared or -approved version (if applicable)
    • to provide a physical copy or electronic updated labeling
    • any other efforts to address or mitigate potential risks of devices that remain distributed after the transition period has ended and the guidances in List 1 of the draft guidance have been withdrawn.
• If the medical device was previously compliant before the declaration of the PHE, and a modified version was distributed after the declaration of the PHE the manufacturer should submit this information as a premarket notification ( i.e., 510(k)) or premarket approval application (PMA) “amendment” to the manufacturer’s existing device submission that was previously cleared or approved.
• FDA recommends that manufacturers notate the following on the cover letter of the submission: “Attention: Notification of Intent”.

By Day 180: Manufacturers should have a marketing submission submitted and accepted by the FDA, meaning FDA has confirmed receipt of the marketing submission.

• The marketing submission/transition implementation plan should address and include:
  • The manufacturers’ plans for devices already distributed in the case of a positive decision or a negative decision.
  • Information regarding the estimated number of devices distributed under the enforcement policy currently in U.S. distribution.
  • A benefit-risk based plan for disposition of distributed product as detailed in the draft guidance.

Moving Forward 

If you do not submit a notification of intent or a marketing submission the FDA is interpreting this as your responsibility to cease distribution of your product. A failure to do so, could leave YOU open to enforcement from the FDA. For scenarios not addressed throughout the transition plan, the FDA allows for manufacturer-initiated discussions with FDA to resolve any issues with medical device registrations. The FDA also invites the trade community to submit comments on these draft guidances before its March 23, 2022 deadline. Please contact us at info@diaztradelaw.com for help submitting your comment!

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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!

Diaz Trade Law’s President, Jennifer Diaz,  and Associate Attorney, Sharath Patil, are enthusiastic to announce that our article, “COVID-19’S IMPACT ON 2020 TRADE FLOWS” was published by the Customs and International Trade Bar Association (CITBA) in its Spring 2021 newsletter. Below is the article for your reading pleasure.

You can read the article here (where you’ll have the ability to access all of the great hyperlinks). Please note you cannot click on the hyperlinks below.

We’d love to hear your feedback!

You can read the article here, by clicking PPE Imports Article (where you’ll have the ability to access all of the great hyperlinks) you cannot click on below.

We’d love to hear your feedback!

Diaz Trade Law regularly counsels all sizes of global clients in import and/or export compliance services. Our expertise is in assisting companies in successfully complying with the vast U.S. Federal Laws and Regulations for import and export transactions.

Diaz Trade Law specializes in customs and international trade matters. Our Customs and International Trade Law attorneys are available at info@diaztradelaw.com or 305-456-3830.