Life Sciences

FDA issues two guidance documents concerning hemodialysis devices

Device Regulation Alert: Safety, Compliance and Reimbursement News, May 19, 2008

In April, the FDA issued two guidance documents addressing FDA submissions for hemodialysis devices.
 
Premarket submissions for hemodialysis blood tubing sets
One guidance offers instruction on how to prepare an abbreviated 510(k) submission before a hemodialysis blood tubing set can be marketed. The submission must address identified risks such as:
  • Device malfunction
  • Infection
  • Ttissue reaction
  • Improper use
  • Blood loss
  • Air embolism
  • Hemolysis
The submission must also describe performance characteristics and functional tests that show the device performs as described. The guidance offers advice on addressing:
  • Device materials and biocompatibility
  • Sterility
  • Labeling
IDEs for nocturnal home hemodialysis devices
The second guidance sets forth the topics that must be addressed before marketing for nocturnal home hemodialysis devices (NHHD) that provide home dialysis therapy to a sleeping patient.

The guidance only applies to NHHD and not conventional hemodialysis. Conventional hemodialysis is provided in a clinical setting by trained medical professionals three times per week. NHHD can be provided at home by the patient or a trained individual while the patient sleeps for up to seven times per week.

The FDA indicates these devices pose a significant risk and advises manufacturers to consult the FDA before submitting 510(k)s or IDEs for the devices. The guidance provides advice on how to describe the device, information to provide concerning prior investigations, and details of the investigational plan.

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