Manufacturers of certain medical devices that are life-sustaining, life-supporting, or intended for use in emergency medical care are now subject to shortage reporting for the first time. The FDA issued guidance implementing the policy, which was introduced under the CARES Act in March.
By Laura DiAngelo, MPH
Executive IQ Brief
- How Things Work Now: Although the FDA has had broad authority to require manufacturers of certain drug products to report shortages, the agency only gained similar authority for medical devices in March 2020. The new section of the Federal Food, Drugs, and Cosmetics (FD&C) Act requires manufacturers of life supporting or sustaining medical devices, or those used in emergent medical care, to report on potential or ongoing shortages to the FDA in times of public health emergency.
- What’s New: On April 6, the FDA issued new final guidance to implement the new Section 506J of FD&C during the COVID-19 public health emergency. The guidance is immediately in effect and will lapse when the emergency is terminated or expires. The guidance outlines what entities are required to report to CDRH, when the reporting has to take place, what information to include, and instructions on notification procedures.
- What’s Next: Medical device manufacturers of devices currently in shortage are going to need to submit reports to the FDA as soon as possible—including manufacturers of PPE, nasal swabs, and other key COVID-19 response items. Even with increased shortage reporting, the FDA may find itself limited in how to effectively respond. Many medical devices and components are imported from other countries which are also facing COVID-19 and dealing with their own supply shortages. The FDA may also find it difficult to inspect alternative sites for inspection based on travel restrictions inside of and outside of the US. However, the CARES Act gave the FDA the authority to expedite and prioritize the review of devices (and facility inspections) “that could help mitigate or prevent” a shortage.
In certain circumstances, the FDA can take limited actions to bolster the supply of medical products in the US in case of shortage. However, the agency’s authority varies depending on the type of medical product.
Under Section 506C of the Food, Drug and Cosmetics Act (FD&C Act), the FDA has the authority to manage shortages of certain medical products, including pharmaceuticals and biologic medicines (collectively defined as “drugs” under the statute). Under this authority, the FDA requires manufacturers of certain life-sustaining, life-supporting, or emergency medical care-supporting drugs to notify the agency of interruptions in the supply chain (i.e., permanent discontinuance, manufacturing issues that lead to a meaningful disruption). Additionally, the FDA can take action to alleviate these drug shortages, including expedited inspections and reviews to shore up the supply through alternative manufacturers.
The FDA has historically not had the same authority to manage medical device supply shortages. The agency has had to rely on voluntary reporting from “essential” medical device manufacturers, which it collects on a quarterly basis. A 2019 regulatory notice indicated that the agency collected information from about 260 manufacturers.
This policy shifted dramatically in March 2020 when Congress passed the Coronavirus Aid, Relief and Economic Security (CARES) Act. The new law includes several significant updates for the FDA, including new authorities to ensure the domestic supply of certain medical products, including medical devices.
Under the CARES Act, the FD&C was amended to add a new section, 505J, giving the FDA the authority to require shortage reporting from device manufacturers in the event of a public health emergency. The legislation states that the manufacturer of any device that is “life-supporting, life-sustaining, or intended for use in emergency medical care or during surgery,” or “for which the Secretary determines” that the device would be needed, would be required to report on a potential shortage or disruption in manufacturing during or in advance of a public health emergency.
The COVID-19 pandemic has led to significant shortages of basic and necessary medical devices needed as part of the medical response. This includes devices like personal protective equipment (PPE), respirators, ventilators and other respiratory equipment, and swabs used in diagnostic test kits. Without the ability to compel manufacturers to report on potential shortages or difficulties in the supply chain, however, the FDA’s response has been largely reactive.
To try to expand the volume and availability of these devices, the FDA has issued guidance expressing significant enforcement discretion, or allowing manufacturers and other entities to not follow the regular rules-of-the-regulatory road for the sake of expediency. For example, the agency is allowing distilleries to make hand sanitizer, manufacturers of respiratory equipment to update their indications for use, and manufacturers of several devices to implement new technology to allow for remote use (e.g., Bluetooth) into their products without regulatory submissions and approval or clearance from the agency. In addition to clearance and approval requirements, the agency has been waving other post-market requirements, such as registration and listing, unique device identifier (UDI), and corrections and removal requirements.
However, the FDA has been generally unable to get out ahead of any impending shortages during the pandemic. Before passing the CARES Act, Congress had been increasingly concerned about the medical device supply chain—and attempted to plug some of those holes in the legislation.
On April 6, the FDA issued new final guidance to implement the new Section 506J of FD&C during the COVID-19 public health emergency, and is “intended to remain in effect only for the duration of the public health emergency related to COVID-19.” The guidance is immediately in effect and will lapse when the emergency is terminated or expires.
The guidance outlines what entities are required to report to CDRH, when the reporting has to take place, what information to include, and instructions on notification procedures.
Who has to notify the FDA?
Manufacturers of all classes of devices (Class I: low risk; Class II: moderate risk; Class III: high risk) are required to report to the FDA under Section 506J. This includes devices that are subject to market access submission requirements (i.e., 510(k) or Premarket Approval (PMA)) as well as exempt device-types that are listed with the FDA. While some low-risk, well-understood devices (e.g., surgical gowns) are not required to be submitted to the agency for review before they are marketed, they are still subject to the reporting requirement.
The agency outlines several criteria by which it will consider if a device is required to report, and recommends manufacturers evaluate their devices based on these criteria.
When should FDA be notified?
Under the law, manufacturers are required to notify the FDA “at least six months in advance” of a meaningful disruption or permanent discontinuance in their supply chain. If the six month lead time is not possible, then the notification should be “as soon as practicable.” In either circumstance, the FDA is recommending that manufacturers submit progress reports every two weeks until the situation is resolved.
Under the guidance, the FDA is defining “as soon as practicable” as within seven calendar days after the disruption. The agency goes on to define “meaningful disruptions” to manufacturing as an issue that would be expected to be resolved within one month.
Interestingly, the agency will also consider increased demand as a factor contributing to “interruptions in manufacturing,” rather than just manufacturing capabilities. This aligns with a recent similar policy change that the FDA undertook for drug shortage reporting. Under that guidance, issued in March, FDA requested that manufacturers notify the agency “when they are unable to meet demand for products” for reasons unrelated to manufacturing disruptions, such as a sudden and unexpected spike in demand.
What should a manufacturer include?
If a device manufacturer identifies that their product meets the statutory criteria and that there is, or is likely to be, a permanent discontinuance or meaningful disruption as defined, they are required to report identifying information to the FDA.
The information should include the marketing submission holder name, the marketing submission number, manufacturer name, FDA Establishment Identifier Number, device name, product code, and appropriate contact information.
As applicable, the manufacturer should include any Unique Device Identifier (UDI) and the device’s trade name. Additioanlly, manufacturers are asked to identify the reason for the discontinuance or interruption from a list, fill out several COVID-19 pandemic-specific questions, production information and inventory supply, and the estimated production capacity and market share.
All of this information should be submitted via email to CDRHManufacturerShortage@fda.hhs.gov
Medical device manufacturers of devices currently in shortage will need to submit reports to the FDA as soon as possible—including manufacturers of PPE, nasal swabs, and other key COVID-19 response items.
Even with increased shortage reporting, the FDA may find itself limited in how to effectively respond. Many medical devices and components are imported from other countries which are also facing COVID-19 and dealing with their own supply shortages. The FDA may also find it difficult to inspect alternative sites for inspection based on travel restrictions inside of and outside of the US. However, the CARES Act gave the FDA the authority to expedite and prioritize the review of devices (and facility inspections) “that could help mitigate or prevent” a shortage.
Going forward, the shortage reporting requirements will only be in effect for medical device manufacturers during formally declared public health emergencies, so it’s unlikely that they will represent a significant new reporting burden in regular times. As AgencyIQ has previously noted, a requirement that all device manufacturers should report on all shortages is generally unnecessary. Due to the design of medical device regulation, which often relies on a comparison between a new market entrant and an existing device (“predicate”), devices generally have more substitutable equivalents than drugs do. Additionally, medical device shortages are more likely to be the result of operational issues, like mergers and acquisitions, increased demand, recalls or lifecycle issues, while drug shortages are often the result of quality issues.
Interestingly, as devices that are being marketed under the enforcement discretion policies are subject to neither clearance/approval nor listing requirements, they will not be subject to shortage reporting either. While the FDA has expressed that the issuance of the enforcement discretion policies were a way to bolster the domestic supply of necessary items, the agency doesn’t have significant insight into how many of these devices are on the market or where they’re being used. Although the enforcement discretion will expire with the public health emergency, without tracking or reporting data on these devices getting them off the market could be difficult for the agency.
Going forward, these regulatory requirements are likely to be refined in future public health emergencies. The drug industry, meanwhile, is still expected updated drug shortage reporting requirements, as indicated in the March guidance.