FDA issues guidance on Premarket Approval (PMA) and Humanitarian Device Exemption (HDE) supplements during COVID-19
The US Food and Drug Administration (FDA) issued a guidance with immediate effect which allows medical device manufacturers to make “limited modifications” to their devices without submitting a premarket approval (PMA), humanitarian device exemption (HDE) supplement or a 30-day notice during the COVID-19 emergency.
The aim of this policy is to grant device manufacturers additional flexibility to address supply chain issues arising from material or component shortages or facility closures due to COVID-19-related disruptions.
“Due to these and other COVID-19 related developments, numerous manufacturers may need to make immediate changes such as adjusting manufacturing processes to allow for social distancing, adapting their manufacturing or design due to supply chain disruption, or to moving device production to a region that is less impacted by COVID-19.”
The policy does not apply to changes made to PMA or HDE devices that are unrelated to manufacturing limitations or supply chain issues caused by COVID-19 and do not extend to changes that have already been included in submissions to the agency.
The guidance includes a list of modifications that would typically require a supplement or notice that would generally be allowable under the policy, as well as a list of changes it says would create an undue risk and would not be allowable without prior submission of a PMA or HDE supplement or notice.
For more details, please see the guidance from FDA.
Meditrial can help – Contact us for immediate support
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.
