US: FDA provides specific performance criteria for cutaneous electrodes and some catheters
The FDA issued the first two device-specific guidances drawing performance criteria to support 510(k) clearance via the new pathway. The FDA had previously proposed an alternate safety and performance based pathway for certain well-understood medical devices. The two final guidances provide performance criteria for cutaneous electrodes for recording purposes and conventional foley catheters. If you are a manufacturer of those device cathegories, reach out to Meditrial to make sure your submission fulfils the new criteria from the FDA.
For more details, please see the following documents from the FDA:
- Cutaneous Electrodes for Recording Purposes – Performance Criteria for Safety and Performance Based Pathway
- Conventional Foley Catheters – Performance Criteria for Safety and Performance Based Pathway
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.
