FDA Outlines Procedures For Companies Expecting COVID-19 Related Product Shortages

The FDA created a new COVID-19 guidelines document detailing when and how medical device manufacturers need to report changes to their products that affect availability. The CARES Act that was signed in late March of 2020 stated that medical device manufacturers that were deemed critical to the COVID-19 emergency by the Secretary of Health and Human Services need to notify the Center for Devices and Radiological Health if they expect an interruption or discontinuation of their product or services. The FDA guidelines document explained what the new rules mean in real time, what companies need to file a notification, and how to do it.

Here are some key highlights of the document:

• The FDA continues to monitor the healthcare industry and supply chain, looking for shortages or other disruptions to the United States supply of necessary medical devices.
• The following device manufacturers must notify the FDA of interruption or discontinuations: (1) devices that are critical to public health during an emergency, such as life-sustaining, life-supporting, and devices intended for medical emergency use or during surgery, and (2) devices in which the FDA deems meaningful in case of supply disruption during a public health emergency.
• Companies must inform the FDA seven calendar days before the expected interruption or delay. They must also provide reasons for the delays, predictions for when they will be back on track, and how the FDA can help during shortages.

Under the Food and Drug Administration Safety and Innovation Act of 2012, the FDA has the right to collect information from companies to help prevent drug shortages. However, until now, no guidelines have been put into place to migrate medical device shortages.

Guidelines Are Extended To Mitigate Shortages

The need for reliable production of medical devices, including ventilators, diagnostics, and face masks, has increased since the coronavirus outbreak began in March. During the United States response to the pandemic, the FDA stated it was monitoring manufacturers in China that might be affected by supply chain disruptions.

In March, the FDA also reminded stakeholders that no law existed requiring medical device companies to disclose information in regards to a shortage. They also were not required to respond to the FDA’s request for information regarding possible supply chain shortages. However, the FDA specifically requested authority over this information in its 2021 budget justification.

The next month, Congress allowed temporary changes to the CARES Act allowing the Federal Food, Drug, and Cosmetic Act to help forewarn the FDA about possible supply chain disruptions that could cause mismanagement of the COVID-19 pandemic.

The FDA’s new guidelines lay out the groundwork that a company must take to properly inform the agency of possible supply shortages. The agency stated that the rules apply to ventilator and thermometer producers that are cleared for sale through the 510(k) pathway. However, it does not apply to unauthorized device makers that are granted enforcement during the crisis.

Devices Must Be Life-Sustaining or Life-Supporting

To determine whether a device-making company must adhere to the new rules, the FDA looks at whether or not a company is life-supporting or life-sustaining or meets an increased demand during the COVID-19 crisis.

Medical device companies are told to notify the FDA of an interruption or discontinuation of a medical part within seven calendar days of the interruption or discontinuation. This deadline is part of the FDA’s interpretation of the CARES ACT, which requires companies to send through notification as soon as possible.

When deciding whether a possible meaningful description is about to occur, companies should only consider their internal availability and not stock that is industry-wide. The guideline document includes example notifications that include the type of information companies must share within their report.

The FDA requested that the companies submit the following details with their notification:

• The reasons for the production disruptions
• The impact of the COVID-19 pandemic on the company’s ability to produce and distribute the device or supplies
• Proposals for how the FDA can help work with the company to migrate the supply disruption

To determine whether or not a device needs to be reported, manufacturing companies may consider the following requirements:

• Whether the device is life-sustaining, life-supporting, or intended to be used in emergency medical care, such as ventilators and ventilator tubing, automated external defibrillators, and hemodialysis equipment
• Whether the device is intended to be used during surgery, such as infusion pumps and tubing or cardiopulmonary bypass oxygenators
• Whether the device is intended to treat, cure, diagnose, mitigate, or prevent COVID-19, such as serological and diagnostic specimen collection kits, pulse oximeters, cardiac and monitoring equipment, and PCR amplification or reagents for extraction for serological testing
• Whether the device is in higher-than-normal demand during the COVID-19 response compared to non-pandemic times, such as personal protective equipment

Meaningful Disruption’ Parameters

According to the new guidelines, the term ‘meaningful disruption’ refers to a change in production that may lead to a reduction in supply of a device that affects the manufacturer's ability to fill orders or meet expected demand. The FDA stated that a manufacturer should base its reporting on its own supplies and not those of their competitors, other manufacturers, or what the market demand currently is.

The term meaningful disruption does NOT include the following:

• Interruptions in manufacturing due to routine maintenance or insignificant manufacturing changes as long as the manufacturer returns to operations shortly (within six months)
• Interruptions in manufacturing of raw materials as long as the interruptions do not cause a shortage in device production and the manufacturer expects to resume operations within a reasonable time (within one month)
• Interruptions in manufacturing that do not cause a reduction in diagnostic tests linked to a medical device that is designed to perform more than one test or procedure. Tests that are intended to perform more than one test or procedure should notify the FDA of any interruptions that could lead to a reduction in any testing capabilities. For example, a device should be reported if it is used for five types of procedures and the manufacturing interruption leaves the device able to perform only four procedures.

FDA Requires Notification ASAP

The FDA does not want companies to wait until they have all of the information regarding their interruption before notifying the FDA. They want companies to send an initial notification to the FDA as soon as they can and then send additional details as soon as more information is available.

The guidelines call for ongoing communication outside of the initial notification. For example, the FDA wants producers with expected interruptions to send an update every two weeks after the initial notification is sent. The FDA expects companies to keep sending updates every two weeks until the issue has been resolved to ensure that all information is up to date.

Per the example listed in the guidelines document, companies must answer questions from the following seven sections:

1. Type of notification (initial or update to previous notification)
2. Identifier information
3. Reason for discontinuance or interruption
4. Duration of discontinuance or interruption
5. COVID-19 specific questions
6. Additional information, such as possible mitigations
7. Production capacity and market share

The FDA intends to keep these policies in place until the coronavirus emergency ends.