The pandemic-driven FDA guidance for device shortages addressed a topic that has been discussed for devices for some time despite lack of congressional action, but shortages may be ordinarily interpreted as a consequence of reduced or terminated production that crimps supplies. That interpretation has been expanded for the duration of the COVID-19 pandemic, however, to include circumstances in which demand exceeds supply even when the manufacturer sustains normal production levels, in which case the manufacturer is liable for reporting the shortage to the FDA.
The agency posted the policy in early May, which stated that the concern revolves around devices deemed critical to public health during the emergency, but not necessarily only to devices used in diagnosis or treatment of COVID-19. The guidance was immediately in effect (IIE) as of the date of publication, but the larger issue of reports of device shortages does not parallel the same question for pharmaceuticals. The statute explicitly requires that drugmakers notify the agency of any shortages, but Congress has never moved to impose a similar mandate on makers of devices and diagnostics.
The FDA has pressed legislators on the point, including in the most recent budget proposal for the FDA and other agencies at the Department of Health and Human Services. The fiscal 2021 budget justification document states that the FDA would like to have the authority to require device makers to notify the agency of “anticipated significant interruption” in the supply chain and to periodically update the agency on the status of any such interruptions. The request also would give the FDA the authority to import devices to cover any critical shortages even if the imported devices carry compliance-related hazards.
Back orders back in vogue for device makers
Katie O’Callaghan, deputy director for strategic programs at the FDA’s device center, noted at the commencement of a webinar for the guidance that the pandemic “triggered an unprecedented increased demand” for some devices. O’Callaghan said the pandemic has also disrupted the med tech supply chain and the normal volume of manufacturing, a predicament that drove at least some of the emergency use authorizations (EUAs) issued by the FDA in recent months.
One of the symptoms of disruption to the supply chain is an accumulation of back orders for products in high demand. This is a scenario that some in industry believe the FDA was not clear on in the text of the guidance, and O’Callaghan noted that the agency sees a shortage as “any time during which demand exceeds supply.” She noted that supplies of products that are on allocation might come up especially short of demand in the pandemic, adding that a shortage “could be as a result of supply-side disruption or increased demand, or a combination of both.” O’Callaghan also advised industry to take note of circumstances in which projected demand might exceed the device maker’s anticipated supply as well.
O’Callaghan went on to explain that part of the EUA strategy was to advise health care professionals on conservation strategies for a variety of devices and instruments, such as personal protective equipment. The agency collaborates with a variety of stakeholders to keep them abreast of any impending shortages, and thus the FDA relies on device manufacturers to keep the agency and others up to date on existing and impending shortages.
Section 506J of the CARES Act temporarily required device makers to advise the FDA of any interruption of cessation of production, particularly when such events may lead to “a meaningful disruption of supply” in the U.S., O’Callaghan said. Among the conditions that would make Section 506J applicable to production of a specific device or diagnostic is when the article is life-supporting or life-sustaining, or is intended for use in emergency medical care. Anything intended for use during surgeries – not limited to patients infected with the SARS-CoV-2 virus – likewise fall under the scope of Section 506J, as is anything that is expected to be the subject of increased demand during the public health emergency.
Conversely, any article that has not received marketing authorization under normal mechanisms, such as PMAs, 510(k)s and de novo designations, but which is authorized under the EAU mechanism, is not subject to this requirement.
As the IIE guidance stated, device makers must advise the agency of an impending shortage at least six months prior to any interruptions to or cessations of production, but device makers must notify the agency within seven days of any cessation/disruption should the six-month notification deadline prove impracticable. O’Callaghan said the associated bi-weekly update requirement for shortages is “important so that we can continue to act on the most current information.”
FDA to device makers: Mind your own shortages
O’Callaghan said the FDA would like industry to make suggestions as to how the agency might aid in efforts to alleviate any shortages, along with production and distribution numbers for the article in question. Any such communications are subject to the trade secret and confidentiality laws to which the FDA is subject, she said. The term of a meaningful disruption to supply is generally a month or longer, but O’Callaghan said device makers are not liable for calculating the effects of other manufacturers’ shortages when assessing their own production volumes.
The manufacturer should report impending or actual shortages even if that manufacturer produces alternative devices that would serve adequately in a pinch, but O’Callaghan asked that industry “connect those dots and say we have these other models” that are not in short supply when reporting to the FDA. This would apply to accessories as well. The FDA recommended that a new shortage not be reported along with an update to an existing shortage, and all shortage communications with the agency can be forwarded to CDRHManufacturerShortage@fda.hhs.gov.