The U.S. Food and Drug Administration (FDA) is soon likely to require human factors data when reviewing pre-market applications for certain types of medical devices.
That’s the import of a draft guidance document “List of Highest Priority Devices for Human Factors Review,” recently released by the agency. Published on February 3, 2016, the draft guidance lists 16 different types of medical devices which the FDA has identified as having a “clear potential for serious harm resulting from use error,” and for which data produced from human factors validation testing should be submitted as part of the pre-market approval process.
The device categories listed in the draft guidance include:
- Ablation generators
- Anesthesia machines
- Artificial pancreas systems
- Auto injectors
- Automated external defibrillators
- Duodenoscopes
- Gastroenterology-urology-endoscopic ultrasound systems
- Hemodialysis and peritoneal dialysis systems
- Implanted infusion pumps
- Insulin delivery systems
- Negative-pressure would therapy
- Robotic catheter manipulation systems
- Robotic surgery devices
- Ventilators
- Ventricular assist devices
Guidance documents are intended to represent the agency’s current perspective on specific topics, and do not have the force of law. However, manufacturers of medical devices in the above categories are encouraged to consider whether human factor validation testing should be conducted prior to seeking FDA approval.
Read the complete text of the FDA’s guidance on human factors considerations in medical devices.
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