This colorized scanning electron microscope image shows SARS-CoV-2 (round blue objects), the virus that causes COVID-19, emerging from the surface of cells cultured in the lab. [Image courtesy of National Institute of Allergy and Infectious Diseases]
Manufacturers can still voluntarily report device production interruptions or permanent discontinuations to the FDA. Patients, healthcare providers, healthcare systems and other stakeholders can also notify the FDA of any supply chain disruptions they’re experiencing by emailing patients, healthcare providers, healthcare systems, distributors, group purchasing organizations) experiencing supply chain disruptions may also notify the FDA by emailing deviceshortages@fda.hhs.gov.
“The FDA encourages device manufacturers to continue to notify the FDA about manufacturing interruptions and discontinuances on a voluntary basis, as such information is essential to our efforts to help prevent and mitigate disruptions in the supply of critical devices,” the agency said.
The FDA’s device shortage list has included personal protective equipment like face masks and gloves, ventilators and testing supplies, as well as automated external defibrillators and other devices affected by a global shortage of semiconductors.
Why is mandatory device shortage reporting ending?
Section 506J of the Federal Food, Drug, and Cosmetic Act mandates the reporting during or in advance of a declared public health emergency. The U.S. Department of Health and Human Services allowed the COVID-19 public health emergency to expire on May 11.
While HHS warned that the FDA will be less able to detect shortages of critical devices related to COVID-19, the agency is “seeking congressional authorization to extend the requirement for device manufacturers to notify FDA of interruptions and discontinuances of critical devices outside of a PHE which will strengthen the ability of FDA to help prevent or mitigate device shortages.”
COVID-19 remains a leading cause of death, along with heart disease and cancer. At least 1.1 million people have died of COVID-19 in the U.S., which is almost certainly an undercount based on excess mortality figures. More than 1,000 people per week are still dying of COVID-19 in the U.S. as recently as this month, and research is showing that survivors of even mild cases face long-term conditions and risks such as long COVID and cardiovascular events.
Related: COVID-19’s mechanisms are becoming clearer, Abbott’s heart failure CMO says
But with new vaccines, tests and treatments developed during the COVID-19 pandemic, HHS said the disease “is no longer the disruptive force it once was.” Deaths are down 95% since January 2021, with hospitalizations down nearly 91% in that same time, HSS said in a fact sheet about the public health emergency’s expiration.
“We are now in a better place in our response than at any point of the pandemic and well-positioned to transition out of the emergency phase,” HHS said. “… So many people continue to be affected by COVID-19, particularly seniors, people who are immunocompromised, and people with disabilities. That is why our response to the spread of SARS-CoV-2, the virus that causes COVID-19, remains a public health priority.”
The FDA has withdrawn its guidance for mandatory reporting during the COVID-19 public health emergency, but is working on updated guidance for requirements under Section 506J.
The agency is also working to finalize a draft guidance published last year: Notifying the FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act.
In addition, the FDA has FAQs about device shortage reporting and more on changes related to the COVID-19 public health emergency’s expiration at its website.
