FDA Changes Reporting Requirements For Medical Device Makers

While there have been rules that required drug makers to report shortages since 2012, the Federal Food & Drug Administration realized there was a problem with the policy after the pandemic hit the United States. With the advent of COVID-19, an unprecedented surge in demand for medical devices and components left most hospitals grappling with dire shortages that cost lives. To better manage these badly needed supplies, the FDA signed the CARES Act into law in March 2020. The legislation requires that medical device makers notify the Center for Devices and Radiological Health (CDRH) of any anticipated manufacturing disruption or discontinuation during a public health emergency.

When manufacturers consider whether a particular product qualifies under the new rules, the FDA urges them to ask themselves whether the device is life-supporting, life-sustaining, or in high demand due to COVID-19. For example, the rules apply to products like ventilators, thermometers, hemodialysis equipment, automatic external defibrillators, cardiopulmonary bypass oxygenators, specimen collection kits, reagents for serological testing, pulse oximeters and other monitoring equipment.

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For those makers with qualifying devices, they must report problems at least six months in advance if there is a significant discontinuance or delay in manufacturing that will negatively impact US supply. If this is not possible, they are to notify the CRDH “as soon as practicable” or within seven calendar days of the occurrence. Federal regulators want to know more than just about the event; they are keen to gather information about the reason for the stoppage, the likely impact the coronavirus will have on the company’s capability for making and shipping the devices, and proposals on how the FDA can help manage the disruption. The agency is asking makers not to wait until they have all the information about a supply shortage before notifying regulators. The priority is for the Center for Devices and Radiological Health to be alerted as soon as possible with information updating as circumstances change.

According to the information given during an FDA webinar held on May 11, Linda Ricci and Katie O'Callaghan of the Science and Strategic Partnerships division stated it was the dialogue between device makers and the FDA that was important. “What may not be widely known is the collaborative work we do in partnership with members of our stakeholder community to identify, address, and mitigate device shortages,” O’Callaghan said. They also invited stakeholders to continue the conversation via biweekly email updates of how their situations were evolving. One departure from the drug shortage provision is that the FDA may decide against making information public about device or component restrictions – mostly to avoid panic buying and stockpiling.