Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis
This draft guidance document was developed as a special control guidance to support the reclassification of the Implanted Blood Access Devices for Hemodialysis into class II (special controls). The device, as proposed, is intended to provide access t..
Original Article: Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis
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