FDA issued indications for medical device manufacturers within the CARES Act: Coronavirus Aid, Relief, and Economic Security Act.

General provisions

Medical device manufacturers are now required to report permanent discontinuance or interruption in manufacturing for the following categories of medical devices:

  • Devices critical to the public health during a public health emergency (for example life-supporting, life-sustaining or intended for use in emergency medical care or surgery); and
  • Devices for which the HHS Secretary determines that information on potential meaningful supply disruptions needed during or in advance of a public health emergency

Timing

Manufacturers need to notify FDA as soon as practicable or at least six months in advance of the discontinuation or interruption.

Non-compliance letters will be submitted to manufacturers who fail to meet the new reporting requirements.

Device shortage

When FDA is notified of a shortage or potential shortage, it will add the device to a publicly available device shortage list.

Manufacturers are now required to maintain and implement risk management plans for devices that are reported as current or potential shortages, and these plans can be examined during FDA inspections or requested in lieu-of or in advance of an inspection.

FDA is also required to prioritize and expedite inspections and the review of submissions or notifications that may assist in resolving shortages

For more details please see the original text of the CARES Act in Part I, Subpart C

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

Contact Meditrial for immediate assistance in Europe or the US.