FDA: Update for medical device manufacturers in CARES Act
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:
- Identify patients requiring follow-up
- Conduct investigator and study nurse calls for training to address the situation
- Obtain authorizations for decentralized data collection
- Support to patients for alternative access to needed care
- Prepare procedures and worksheets for remote collection of patient clinical data
- Monitor work instructions and trainings for site support and remote monitoring
- EDC and ePRO solutions to enable study continuity
- Privacy protection measures
Contact Meditrial for immediate assistance in Europe or the US.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
