Home » Draft Guidance Sets Special Controls for Implanted Blood Access Devices
Draft Guidance Sets Special Controls for Implanted Blood Access Devices
510(k) submissions for implanted blood access devices for hemodialysis must demonstrate the biocompatibility of all components that come into human contact, an FDA draft guidance states. If companies are unable to identify a predicate device with identical location/duration of contact and materials, manufacturers should conduct biocompatibility tests.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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