Written by Michelle Rubin-Onur, PhD, Director of Regulatory at Enzyme
Life as we knew it changed drastically in 2020 when, on January 31, 2020, the Secretary of Health and Human Services (HHS) declared COVID-19 a public health emergency (PHE). Aligning with this declaration, FDA released numerous guidance documents (see the list at the end of this post) which reflected a shift in regulatory enforcement to address Americans’ needs. This flexibility, called enforcement discretion, allowed Americans to have access to numerous medical devices, including but not limited to face masks, infusion pumps, sterilizers, ventilators, and digital health devices to treat psychiatric disorders, that would traditionally undergo FDA review and clearance/approval without this review. Although this was good for the American public, there was always an outstanding question of what would happen once the PHE ended: How would FDA approach these medical devices and regulate them again?
We received some insight into FDA’s approach and thinking when the finalized guidance focused on transitioning medical devices from enforcement discretion was released on March 27, 2023. The transition plan, which lasts 180 days, includes three phases: Phase 1, Phase 2, and Phase 3 (Figure 1) and applies to all of the devices listed at the end of this blog post, each of which was the subject of a product-specific guidance under the enforcement policy umbrella. The list includes, but is not limited to:
- Remote digital pathology devices
- Imaging systems, including CT, MRI, and a number of X-ray imaging configurations
- Non-invasive fetal/maternal monitoring devices
- Digital devices for treatment of psychiatric disorders
- Extracorporeal membrane oxygenation and cardiopulmonary bypass devices
Figure 1. Timeline for transition plan. Taken directly from the FDA guidance.
Phase 1: May 11 – August 8, 2023
The first phase of the plan began on May 11, 2023, when the Secretary of HHS declared the end of the PHE. This phase included two recommended actions:
- Adverse event reporting (as required under 21 CFR 803) in preparation for Phase 3
- If the manufacturer intends to continue distribution of their device after Phase 2, begin preparation of any required marketing submission
Part of preparation of a marketing submission is consideration of what clinical data, if any, could support the submission. Aligning with FDA’s commitment to consider real-world evidence and real-world data, FDA clearly states in the guidance that if manufacturers collected any real-world data drawn from use during the COVID-19 pandemic, it may be used in premarket submissions.
A unique feature of any marketing submission for any device that was under enforcement discretion during the PHE is the Transition Implementation Plan (TIP). The TIP should be included in the cover letter of the submission and should include the following information. For a more detailed list of what should be included in the TIP, please refer to the guidance.
- Estimated number of devices currently in U.S. distribution
- Explanation of the benefit-risk based plan for disposition of devices already in distribution in the event of a negative decision
- Explanation of the benefit-risk based plan for disposition of devices already in distribution in the event of a positive decision
Part of what device manufacturers should consider when drafting the TIP is whether the device is considered “already distributed” and/or “in distribution”. As defined by the guidance, devices are considered to be “already distributed” if they are finished devices that are labeled and are in distribution in the U.S. supply chain or are in the possession of the end user. For purposes of this guidance, FDA would generally consider devices to be “in distribution” to mean those finished, labeled devices that are no longer in the manufacturer’s possession that are in transit to or held in a third party’s device inventory not on behalf of the manufacturer, in a federal, state, or other government stockpile, or at a location where devices are then offered for direct sale to the end user.”
Phase 2: August 9 – November 6, 2023
Phase 2 began 90 days after the PHE expiration on August 9, 2023. This phase includes four new recommended actions (manufacturers should continue to follow the considerations from Phase 1, as applicable):
- Even prior to the start of Phase 2, manufacturers should follow correction and removal requirements (per 21 CFR Part 806).
- Before Phase 2, if the manufacturer intends to continue to distribute their device, the manufacturer should register their establishment(s) and list their device(s) or update their existing registration and listing prior to the start of Phase 2. FDA recommended that manufacturers utilize the term “enforcement” in the premarket submission field if a submission hasn’t been submitted yet.
- Submit a “Notification of Intent” for certain reusable life supporting or life sustaining devices.
- Submit marketing submission during this phase to ensure acceptance prior to the start of Phase 3 to avoid disruptions.
A “Notification of Intent” is a document that manufacturers of certain reusable life-supporting or life-sustaining devices need to submit to FDA informing the Agency whether the manufacturer intends to submit a marketing submission to FDA and continue distributing the device after Phase 2. The document submitted should follow the structure and recommended content listed in the guidance.
Given the nature of these devices (Table 1), providing this information to FDA assists in resource planning sufficient support of device manufacturers to reduce the likelihood of any device unavailability. If another version of the device is FDA-cleared or -approved, and a modified version was distributed during the PHE, FDA recommends that the modified version is submitted for review (e.g., a new 510(k) Premarket Notification or PMA “amendment”).
|Product Code||Device Type||Classification Regulation|
|BSZ||Gas-machine, Anesthesia||21 CFR 868.5160|
|CAW||Generator, Oxygen, Portable||21 CFR 868.5440|
|BTT||Humidifier, Respiratory Gas, (Direct Patient Interface)||21 CFR 868.5450|
|QAV||High Flow/High Velocity Humidified Oxygen Delivery Device||21 CFR 868.5454|
|CBK||Ventilator, Continuous, Facility Use||
21 CFR 868.5895
|MNT||Ventilator, Continuous, Minimal Ventilatory Support, Facility Use|
|NOU||Ventilator, Continuous, Home Use|
|MNS||Ventilator, Continuous, Non-Life-Supporting|
|BTL||Ventilator, Emergency, Powered (Resuscitator)||21 CFR 868.5925|
Table 1. “Notification of Intent” devices
For manufacturers that don’t intend to continue to distribute their device after Phase 2, the guidance highlights that FDA does not intend to object to the disposition and use of already distributed devices (e.g., devices in the supply chain or already in the hand of users) as follows:
- Single-use, non-life sustaining/non-life supporting devices distributed prior to the end of Phase 2 used prior to the product expiration
- Reusable, non-life supporting/non-life sustaining devices distributed prior to the end of Phase 2 that are either restored to the previous FDA-cleared or -approved version or have updated labeling that accurately describes product features and regulatory status
- Reusable life supporting/life sustaining devices distributed prior to the end of Phase 2 that are restored to the FDA-cleared or -approved version
Phase 3: November 7, 2023 – onward
Phase 3 begins on November 7, 2023, 180 days after the PHE expiration. At this point, all of the COVID-19 related enforcement policies listed in the guidance will no longer be in effect. This phase has two recommended actions:
- Prior to the beginning of this phase, if manufacturers intend to keep their devices on the market, the applicable marketing submission needs to be submitted and accepted for review prior to the beginning of Phase 3. For manufacturers that have not submitted a marketing submission, had it accepted, or have already received a negative decision on their submission, FDA expects that the manufacturers will discontinue distribution of their device.
- For devices that are accepted for review prior to Phase 3, FDA does not intend to object to the continued distribution of these devices. For such devices, until a final decision is made by FDA, FDA will not object if devices do not comply with specific labeling requirements, including having a unique device identifier (see 21 CFR 801). Keep in mind that FDA still maintains the ability to make case-by-case decisions regarding the enforcement of legal requirements.
Please note, the policy relating to FDA marketing authorization and labeling requirements does not apply to other legal requirements that were part of the previous phases, such as registration and listing, having a quality system, and reporting corrections and removals. Moreover, once FDA makes a final decision regarding the marketing submission, FDA expects manufacturers to comply with all applicable regulatory requirements, as well as follow the steps outlined in the Transition Implementation Plan included in the marketing submission.
A unique part of this guidance is language around how FDA will address any questions received from stakeholders (e.g., other agencies, governmental stockpilers, healthcare providers). Typically, if a device is FDA-cleared, -approved, or authorized under an Emergency Use Authorization, this information is publicly available. Aligning with existing procedures, the existence of a marketing submission will not typically be disclosed. For devices that have a version already FDA-cleared or -approved, FDA may share with stakeholders that the manufacturer is distributing the device per the process and policy described in the guidance, indirectly revealing that a marketing submission is under review.
The guidance also speaks to quality system considerations. For example, non-traditional device manufacturers that were following different quality requirements may require more time to transition to 21 CFR Part 820. In such cases, for manufacturers that want to continue to distribute their devices beyond Phase 2, they may apply for an exception or a variance. Any such requests should already be on file with the FDA at the onset of Phase 2 (within 90 days of the PHE expiration) to ensure the agency will be able to process the request on time.
As evident in this blog post, the guidance addresses a long and dense topic that includes multiple steps and considerations. Although we are already well into Phase 2, if you are a manufacturer of a device that falls under this guidance and have not started yet, don’t hesitate to reach out to Enzyme. We are happy to walk you through the guidance in more detail and assist in helping you transition from enforcement discretion to regulated medical device.
Enforcement Policy guidance documents:
- Enforcement Policy for Remote Digital Pathology Devices During the COVID-19 Public Health Emergency
- Enforcement Policy for Imaging Systems During the COVID-19 Public Health Emergency
- Enforcement Policy for Non-Invasive Fetal and Maternal Monitoring Devices Used to Support Patient Monitoring During the COVID-19 Public Health Emergency
- Enforcement Policy for Telethermographic Systems During the COVID-19 Public Health Emergency
- Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 Public Health Emergency
- Enforcement Policy for Extracorporeal Membrane Oxygenation and Cardiopulmonary Bypass Devices During the COVID-19 Public Health Emergency
- Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices During the COVID-19 Public Health Emergency
- Enforcement Policy for Infusion Pumps and Accessories During the COVID-19 Public Health Emergency
- Enforcement Policy for Face Shields, Surgical Masks, and Respirators During the COVID-19 Public Health Emergency
- Enforcement Policy for Gowns, Other Apparel, and Gloves During the COVID-19 Public Health Emergency
- Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the COVID-19 Public Health Emergency
- Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the COVID-19 Public Health Emergency
- Enforcement Policy for Modifications to FDA Cleared Molecular Influenza and RSV Tests During the COVID-19 Public Health Emergency
- Coagulation Systems for Measurement of Viscoelastic Properties: Enforcement Policy During the COVID-19 Public Health Emergency (Revised)
- Enforcement Policy for Viral Transport Media During the COVID-19 Public Health Emergency (Revised)