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Draft Guidance on Medical Device Transition Period

In response to the COVID-19 Pandemic, the FDA took unprecedented action in transforming its enforcement because of the declaration of a Public Health Emergency while also issuing, and continuing, Emergency Use Authorizations. These governmental actions facilitated and increased the importation of necessary medical devices needed to combat the pandemic here in the United States. And now as the U.S. relaxes its pandemic protocol, the FDA is exploring the best way to have medical devices transition back to pre-pandemic regulations and protocol. On December 23, 2021, the FDA issued two draft guidance documents in the Federal Register detailing its proposed medical device transition plans for all medical devices previously imported under the two aforementioned government declarations. And to provide further assistance, the FDA hosted a webinar “Draft Guidances on Transition Plans for COVID-19 Related Medical Devices” providing further explanations to the trade community on what can be expected from the proposed transition plans.

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  The draft guidance recommends that manufacturers of such devices include in this notification: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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The post Draft Guidance on Medical Device Transition Period appeared first on Customs & International Trade Law Blog.

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