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:
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.
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:
To determine whether or not a device needs to be reported, manufacturing companies may consider the following requirements:
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:
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:
The FDA intends to keep these policies in place until the coronavirus emergency ends.