COVID-19 Business Intelligence and Analysis for Clinical Laboratories, Pathology Groups and Hospital Administration

COVID-19 Briefings

Reliable COVID-19 Business Intelligence and analysis for clinical laboratories, pathology groups and Laboratory Diagnostics.

FDA Enhances Medical Device Shortage Resources to Better Reflect the Needs of Clinical Laboratories

FDA maze of regulations

Newly updated FDA resource pages may help clinical laboratories with their supply chain issues

The US Food and Drug Administration (FDA) announced in late December 2020 a medical Device Shortage List update to reflect types of testing supplies that were not previously included. The primary testing supplies that were not previously included were pipette tips and micropipettes, although other changes were also made. The FDA also made changes to how devices are categorized, which may make it easier for clinical laboratories to search specifically for testing supplies and equipment shortages.

The FDA also announced the release of a new web page supporting the Device Shortage List. This page includes frequently asked questions (FAQs) about FDA-identified supply shortages. The questions on this list include:

  1. “Who should submit a notice of an interruption or discontinuance in the manufacturing of a product during the COVID-19 Public Health Emergency?”
  2. “How does the FDA determine what devices are in shortage?”
  3. “Are there additional resources to consult if I cannot find supplies of the devices on the Device Shortage List?”
  4. “I can’t obtain a product, and it is not on this list. Why isn’t the device on this list?”
  5. “What does the FDA do with information about medical device shortages?”
  6. “Who can I contact if I have additional questions?”

Clinical laboratories that are experiencing supply chain issues can leverage this recently improved resource to better manage supply chain problems and anticipate shortages before they are experienced.

Related Resources:

FDA: Medical Device Shortages During the COVID-19 Public Health Emergency

FDA: Supplies of Medical Devices for COVID-19: Frequently Asked Questions