Medicare Compliance & Reimbursement

Industry Notes:

FDA Updates Device Shortage List and FAQ

In an effort to be more transparent, the Food and Drug Administration (FDA) has updated its device shortage list as well as its Frequently Asked Questions (FAQ).

Now: As the pandemic stretches on, medical device and healthcare equipment shortages continue to plague providers and slow down services. On Dec. 23, the FDA added new items to the list and refreshed information on existing shortages.

“The list fulfills a statutory obligation under section 506J of the FD&C Act and reflects the categories of devices the FDA has determined to be in shortage at this time and will be maintained and updated as the COVID-19 public health emergency evolves,” an FDA release said. “The presence of a device type on this list does not necessarily indicate that patient care has been affected,” the agency added.

Personal protective equipment (PPE), testing supplies, and ventilators continue to top the shortage list.

Plus: In addition to its shortage list, the FDA has put together a new online FAQ to answer provider and patient questions on a variety of topics like how a shortage is determined, device resource information, and acquiring items.

Resources: See the updated shortage list at www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency and visit the FAQ at www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/supplies-medical-devices-covid-19-frequently-asked-questions.